An interventional study of BAL fluid sampling and Nasopharyngeal swab sampling in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 7 sites in Spain. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Other
Among 64 studies in Streptococcal Infections by GlaxoSmithKline — 1 open to participants now, 1 under way, none of them phase 3. Streptococcal Infections · GlaxoSmithKline.
Among the 64 studies in Streptococcal Infections by GlaxoSmithKline, this one is the 43rd largest by enrollment of the 55 interventional ones that give a count, is one of 3 that started in 2013, is the only one with no phase, and was the 62nd registered.
146 studies on the registry are indexed under Streptococcal Infections; 14 are open to participants now.
Browse Streptococcal Infections studies →1 of the 64 studies in Streptococcal Infections by GlaxoSmithKline is open now, in 1 country. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Australia
Ages 18–25 · Healthy volunteers
By country, each count listing its studies:
Of the 10 Streptococcal Infections studies recruiting now, 6 (60%) set no upper age limit and 3 (30%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 6 Months to 6 Years · all sexes · no healthy volunteers.
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64 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 197 is below the median of 270 across 106 interventional studies indexed under Streptococcal Infections.
Median enrollment 365 across the 55 interventional studies, 50 across the 9 observational. Of the 61 that completed or were terminated, 44 (72%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
1 of the studies in Streptococcal Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07085702GlaxoSmithKlineA Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults | 2027-06-29 |
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Among the 64 studies in Streptococcal Infections by GlaxoSmithKline, from their registry updates:
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The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL).
Other: BAL fluid sampling · Other: Nasopharyngeal swab sampling
Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.
1 swab, Day 0
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 up to Year 2
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Time frame: From Day 0 up to Year 2
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.). Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 up to Year 2
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load \>10\^5 cfu/mL if presented as co-infection. Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Time frame: From Day 0 up to Year 2
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included: Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
Time frame: From Day 0 and up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
Time frame: From Day 0 and up to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Time frame: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Time frame: From Day 0 to Year 2
Mean Age of Subjects
Demographic characteristics included age, which was expressed in months.
Time frame: From Day 0 to Year 2
Subject Gender
Demographic characteristics included gender: female and male.
Time frame: From Day 0 to Year 2
Mean Weight of Subjects
Demographic characteristics included weight which was expressed in kilograms (kg).
Time frame: From Day 0 to Year 2
Mean Height of Subjects
Demographic characteristics included height which was expressed in centimeters (cm).
Time frame: From Day 0 to Year 2
Number of Subjects With Body Mass Index (BMI) Characteristics
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
Time frame: From Day 0 to Year 2
Number of Subjects Presenting General Medical History Characteristics
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
Time frame: From Day 0 to Year 2
Mean Gestational Age of Subjects
General medical history included mean gestational age.
Time frame: From Day 0 to Year 2
Number of Subjects With Pneumococcal Vaccination History Characteristics
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
Time frame: From Day 0 to Year 2
Number of Subjects With Flu Vaccination History Characteristics
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
Time frame: From Day 0 to Year 2
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
Time frame: From Day 0 to Year 2
Number of Subjects With Antibiotics and Other Medications Administered
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
Time frame: From Day 0 to Year 2
Number of Subjects With Clinical Characteristics
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
Time frame: From Day 0 to Year 2
Number of Subjects With Laboratory Results
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC \[LRTI-WBC\], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP \[LRTI-CRP\], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR \[LRTI-ESR\].
Time frame: From Day 0 to Year 2
White Blood Cells (WBC) Laboratory Results
Laboratory results for WBC were expressed in 10\^9 cells per liter (10\^9 cells/L).
Time frame: From Day 0 to Year 2
C-reactive Protein (CRP) Laboratory Results
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
Time frame: From Day 0 to Year 2
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
Time frame: From Day 0 to Year 2
Number of Subjects With Radiological Results
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
Time frame: From Day 0 to Year 2
| Milestone | Total Group |
|---|---|
| Started | 197 |
| Completed | 197 |
| Not completed | 0 |
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Participants | Total Group |
|---|---|
| Pos. qualitative B.I. for any of the 3 bacteria | 141 |
| Neg. qualitative B.I. for any of the 3 bacteria | 49 |
| Mis. qualitative B.I. for any of the 3 bacteria | 1 |
| Pos. qualitative B.I. for S. pneumoniae | 58 |
| Neg. qualitative B.I. for S. pneumoniae | 132 |
| Mis. qualitative B.I. for S. pneumoniae | 1 |
| Pos. qualitative B.I. for H. influenzae | 97 |
| Neg. qualitative B.I. for H. influenzae | 93 |
| Mis. qualitative B.I. for H. influenzae | 1 |
| Pos. qualitative B.I. for M. catarrhalis | 94 |
| Neg. qualitative B.I. for M. catarrhalis | 96 |
| Mis. qualitative B.I. for M. catarrhalis | 1 |
| Pos. qualitative B.I. for other bacteria | 12 |
| Neg. qualitative B.I. for other bacteria | 0 |
| Mis. qualitative B.I. for other bacteria | 179 |
| Pos. quantitative B.I. for any of the 3 bacteria | 42 |
| Neg. quantitative B.I. for any of the 3 bacteria | 148 |
| Mis. quantitative B.I. for any of the 3 bacteria | 1 |
| Pos. quantitative B.I. for S. pneumoniae | 20 |
| Neg. quantitative B.I. for S. pneumoniae | 170 |
| Mis. quantitative B.I. for S. pneumoniae | 1 |
| Pos. quantitative B.I. for H. influenzae | 17 |
| Neg. quantitative B.I. for H. influenzae | 173 |
| Mis. quantitative B.I. for H. influenzae | 1 |
| Pos. quantitative B.I. for M. catarrhalis | 12 |
| Neg. quantitative B.I. for M. catarrhalis | 178 |
| Mis. quantitative B.I. for M. catarrhalis | 1 |
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or \>10\^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
| Participants | Total Group |
|---|---|
| S.p. alone (B.I. >10^4 cfu/mL) | 15 |
| H.i. alone (B.I. >10^4 cfu/mL) | 14 |
| M.c. alone (B.I. >10^4 cfu/mL) | 6 |
| Other bacterial pathogens - Any load | 12 |
| Other bacterial pathogens alone - Any load | 10 |
| S.p. and H.i. (B.I. >10^5 cfu/mL) | 1 |
| S.p. and M.c. (B.I. >10^5 cfu/mL) | 4 |
| H.i. and M.c. (B.I. >10^5 cfu/mL) | 2 |
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.). Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Participants | Total Group |
|---|---|
| N.M.c.-N.S.p.-N.H.i. | 148 |
| N.M.c.-N.S.p.-P.H.i. | 14 |
| N.M.c.-P.S.p.-N.H.i. | 15 |
| N.M.c.-P.S.p.-P.H.i. | 1 |
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (\>) 10\^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load \>10\^5 cfu/mL if presented as co-infection. Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification \>10\^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
| Participants | Total Group |
|---|---|
| P.M.c.-N.S.p.-N.H.i. | 6 |
| P.M.c.-N.S.p.-P.H.i. | 2 |
| P.M.c.-P.S.p.-N.H.i. | 4 |
| P.M.c.-P.S.p.-P.H.i. | 0 |
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
| Participants | Total Group |
|---|---|
| Pos. qualitative B.I. for any of the 3 bacteria | 154 |
| Neg. qualitative B.I. for any of the 3 bacteria | 37 |
| Pos. qualitative B.I. for S. pneumoniae | 99 |
| Neg. qualitative B.I. for S. pneumoniae | 92 |
| Pos. qualitative B.I. for H. influenzae | 89 |
| Neg. qualitative B.I. for H. influenzae | 102 |
| Pos. qualitative B.I. for M. catarrhalis | 107 |
| Neg. qualitative B.I. for M. catarrhalis | 84 |
| Pos. quantitative B.I. for any of the 3 bacteria | 37 |
| Neg. quantitative B.I. for any of the 3 bacteria | 154 |
| Pos. quantitative B.I. for S. pneumoniae | 24 |
| Neg. quantitative B.I. for S. pneumoniae | 167 |
| Pos. quantitative B.I. for H. influenzae | 7 |
| Neg. quantitative B.I. for H. influenzae | 184 |
| Pos. quantitative B.I. for M. catarrhalis | 10 |
| Neg. quantitative B.I. for M. catarrhalis | 181 |
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| cfu/mL | Total Group |
|---|---|
| S. pneumoniae Bacterial load | 4.28 ± 1.04 |
| H. influenzae Bacterial load | 3.81 ± 1.11 |
| M. catarrhalis Bacterial load | 3.54 ± 1.01 |
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| cfu/mL | Total Group |
|---|---|
| S. pneumoniae Bacterial load | 4.06 ± 1.27 |
| H. influenzae Bacterial load | 4.31 ± 1.32 |
| M. catarrhalis Bacterial load | 3.92 ± 1.29 |
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included: Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Participants | Total Group |
|---|---|
| Staphylococcus aureus (Growth) | 1 |
| Pseudomonas aeruginosa (Growth) | 5 |
| Stenotrophomonas maltophilia (Growth) | 4 |
| Pseudomonas putida (Growth) | 2 |
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
| cfu/mL | Total Group |
|---|---|
| S. pneumoniae Bacterial load | 3.99 ± 1.15 |
| H. influenzae Bacterial load | 3.61 ± 0.88 |
| M. catarrhalis Bacterial load | 3.36 ± 1.05 |
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load \>10\^4 cfu/mL if present alone or \> 10\^5 cfu/mL if present as co-infection.
| cfu/mL | Total Group |
|---|---|
| S. pneumoniae Bacterial load | 4.39 ± 1.13 |
| H. influenzae Bacterial load | 4.16 ± 1.17 |
| M. catarrhalis Bacterial load | 4.05 ± 1.24 |
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
| Participants | Total Group |
|---|---|
| Staphylococcus aureus (Growth) | 6 |
| Stenotrophomonas maltophilia (Growth) | 1 |
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| 3 | 2 |
| 6B | 4 |
| 7C | 1 |
| 10A | 3 |
| 11A | 1 |
| 11D | 4 |
| 12F | 1 |
| 14 | 3 |
| 15B | 1 |
| 16F | 2 |
| 18C | 1 |
| 18F | 10 |
| 19A | 3 |
| 19F | 4 |
| 21 | 4 |
| 22F | 2 |
| 23A | 4 |
| 23B | 1 |
| 31 | 4 |
| 35F | 3 |
| 42 | 2 |
| 48 | 1 |
| NT | 4 |
| Synflorix serotypes | 15 |
| PCV13 serotypes | 17 |
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| f | 3 |
| NT | 95 |
S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
| unique isolates of subjects | Total Group |
|---|---|
| 3 | 2 |
| 6A | 1 |
| 6B | 6 |
| 7C | 2 |
| 9N | 1 |
| 10A | 5 |
| 11A | 1 |
| 11D | 5 |
| 12B | 1 |
| 12F | 3 |
| 14 | 2 |
| 16F | 3 |
| 18C | 1 |
| 18F | 14 |
| 19A | 6 |
| 19C | 1 |
| 19F | 9 |
| 21 | 7 |
| 23A | 5 |
| 23B | 2 |
| 31 | 3 |
| 35A | 1 |
| 35F | 3 |
| 42 | 6 |
| 48 | 4 |
| NT | 11 |
| Synflorix serotypes | 24 |
| PCV13 serotypes | 27 |
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
| unique isolates of subjects | Total Group |
|---|---|
| f | 4 |
| NT | 88 |
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| Sus. Penicilin (BALF) | 36 |
| Int. Penicilin (BALF) | 13 |
| Res. Penicilin (BALF) | 16 |
| Sus. Penicilin (NPS) | 55 |
| Int. Penicilin (NPS) | 27 |
| Res. Penicilin (NPS) | 23 |
| Sus. Amoxicillin/ Clavulanate (BALF) | 50 |
| Int. Amoxicillin/ Clavulanate (BALF) | 7 |
| Res. Amoxicillin/ Clavulanate (BALF) | 8 |
| Sus. Amoxicillin/ Clavulanate (NPS) | 86 |
| Int. Amoxicillin/ Clavulanate (NPS) | 10 |
| Res. Amoxicillin/ Clavulanate (NPS) | 9 |
| Sus. Erythromycin (BALF) | 43 |
| Int. Erythromycin (BALF) | 1 |
| Res. Erythromycin (BALF) | 21 |
| Sus. Erythromycin (NPS) | 55 |
| Int. Erythromycin (NPS) | 1 |
| Res. Erythromycin (NPS) | 49 |
| Sus. Azithromycin (BALF) | 41 |
| Int. Azithromycin (BALF) | 3 |
| Res. Azithromycin (BALF) | 21 |
| Sus. Azithromycin (NPS) | 57 |
| Int. Azithromycin (NPS) | 4 |
| Res. Azithromycin (NPS) | 44 |
| Sus. Tetracycline (BALF) | 51 |
| Int. Tetracycline (BALF) | 14 |
| Res. Tetracycline (BALF) | 0 |
| Sus. Tetracycline (NPS) | 71 |
| Int. Tetracycline (NPS) | 3 |
| Res. Tetracycline (NPS) | 31 |
| Sus. Levofloxacin (BALF) | 65 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 103 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 2 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 24 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 13 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 28 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 52 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 13 |
| Res. Trimethoprim/Sulfamethoxazole (NPS) | 40 |
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| Sus. Amoxicillin/ Clavulanate (BALF) | 91 |
| Int. Amoxicillin/ Clavulanate (BALF) | 0 |
| Res. Amoxicillin/ Clavulanate (BALF) | 7 |
| Sus. Amoxicillin/ Clavulanate (NPS) | 91 |
| Int. Amoxicillin/ Clavulanate (NPS) | 0 |
| Res. Amoxicillin/ Clavulanate (NPS) | 1 |
| Sus. Azithromycin (BALF) | 95 |
| Int. Azithromycin (BALF) | 0 |
| Res. Azithromycin (BALF) | 3 |
| Sus. Azithromycin (NPS) | 89 |
| Int. Azithromycin (NPS) | 0 |
| Res. Azithromycin (NPS) | 3 |
| Sus. Tetracycline (BALF) | 98 |
| Int. Tetracycline (BALF) | 0 |
| Res. Tetracycline (BALF) | 0 |
| Sus. Tetracycline (NPS) | 92 |
| Int. Tetracycline (NPS) | 0 |
| Res. Tetracycline (NPS) | 0 |
| Sus. Levofloxacin (BALF) | 98 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 92 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 0 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 51 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 16 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 31 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 49 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 18 |
| Res. Trimethoprim/Sulfamethoxazole (NPS) | 25 |
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| Penicilin (BALF) | 0.5 (0.13 to 16.00) |
| Penicilin (NPS) | 0.5 (0.13 to 16.00) |
| Erythromycin (BALF) | 4 (1.00 to 16.00) |
| Erythromycin (NPS) | 4.00 (0.25 to 16.00) |
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| Sus. Amoxicillin/Clavulanate (BALF) | 95 |
| Int. Amoxicillin/Clavulanate (BALF) | 0 |
| Res. Amoxicillin/Clavulanate (BALF) | 3 |
| Sus. Amoxicillin/Clavulanate (NPS) | 105 |
| Int. Amoxicillin/Clavulanate (NPS) | 0 |
| Res. Amoxicillin/Clavulanate (NPS) | 5 |
| Sus. Erythromycin (BALF) | 90 |
| Int. Erythromycin (BALF) | 0 |
| Res. Erythromycin (BALF) | 8 |
| Sus. Erythromycin (NPS) | 106 |
| Int. Erythromycin (NPS) | 0 |
| Res. Erythromycin (NPS) | 4 |
| Sus. Azithromycin (BALF) | 84 |
| Int. Azithromycin (BALF) | 0 |
| Res. Azithromycin (BALF) | 14 |
| Sus. Azithromycin (NPS) | 106 |
| Int. Azithromycin (NPS) | 0 |
| Res. Azithromycin (NPS) | 4 |
| Sus. Tetracycline (BALF) | 98 |
| Int. Tetracycline (BALF) | 0 |
| Res. Tetracycline (BALF) | 0 |
| Sus. Tetracycline (NPS) | 110 |
| Int. Tetracycline (NPS) | 0 |
| Res. Tetracycline (NPS) | 0 |
| Sus. Levofloxacin (BALF) | 98 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 110 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 0 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 56 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 35 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 7 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 103 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 7 |
| Res. Trimethoprim/Sulfamethoxazole(NPS) | 0 |
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| Penicilin (BALF) | 8.00 (0.02 to 16.00) |
| Penicilin (NPS) | 16.00 (0.02 to 16.00) |
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| unique isolates of subjects | Total Group |
|---|---|
| H. influenzae (BALF) | 7 |
| H. influenzae (NPS) | 9 |
| M. catarrhalis (BALF) | 93 |
| M. catarrhalis (NPS) | 108 |
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| Sus. Penicilin (BALF) | 15 |
| Int. Penicilin (BALF) | 2 |
| Res. Penicilin (BALF) | 4 |
| Sus. Penicilin (NPS) | 11 |
| Int. Penicilin (NPS) | 10 |
| Res. Penicilin (NPS) | 5 |
| Sus. Amoxicillin/Clavulanate (BALF) | 17 |
| Int. Amoxicillin/Clavulanate (BALF) | 3 |
| Res. Amoxicillin/Clavulanate (BALF) | 1 |
| Sus. Amoxicillin/Clavulanate (NPS) | 22 |
| Int. Amoxicillin/Clavulanate (NPS) | 3 |
| Res. Amoxicillin/Clavulanate (NPS) | 1 |
| Sus. Erythromycin (BALF) | 17 |
| Int. Erythromycin (BALF) | 0 |
| Res. Erythromycin (BALF) | 4 |
| Sus. Erythromycin (NPS) | 11 |
| Int. Erythromycin (NPS) | 0 |
| Res. Erythromycin (NPS) | 15 |
| Sus. Azithromycin (BALF) | 15 |
| Int. Azithromycin (BALF) | 2 |
| Res. Azithromycin (BALF) | 4 |
| Sus. Azithromycin (NPS) | 11 |
| Int. Azithromycin (NPS) | 2 |
| Res. Azithromycin (NPS) | 13 |
| Sus. Tetracycline (BALF) | 18 |
| Int. Tetracycline (BALF) | 0 |
| Res. Tetracycline (BALF) | 3 |
| Sus. Tetracycline (NPS) | 16 |
| Int. Tetracycline (NPS) | 1 |
| Res. Tetracycline (NPS) | 9 |
| Sus. Levofloxacin (BALF) | 21 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 25 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 1 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 3 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 5 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 13 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 12 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 2 |
| Res. Trimethoprim/Sulfamethoxazole (NPS) | 12 |
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcomes description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| Sus. Amoxicillin/Clavulanate (BALF) | 15 |
| Int. Amoxicillin/Clavulanate (BALF) | 0 |
| Res. Amoxicillin/Clavulanate (BALF) | 3 |
| Sus. Amoxicillin/Clavulanate (NPS) | 8 |
| Int. Amoxicillin/Clavulanate (NPS) | 0 |
| Res. Amoxicillin/Clavulanate (NPS) | 0 |
| Sus. Azithromycin (BALF) | 17 |
| Int. Azithromycin (BALF) | 0 |
| Res. Azithromycin (BALF) | 1 |
| Sus. Azithromycin (NPS) | 8 |
| Int. Azithromycin (NPS) | 0 |
| Res. Azithromycin (NPS) | 0 |
| Sus. Tetracycline (BALF) | 18 |
| Int. Tetracycline (BALF) | 0 |
| Res. Tetracycline (BALF) | 0 |
| Sus. Tetracycline (NPS) | 8 |
| Int. Tetracycline (NPS) | 0 |
| Res. Tetracycline (NPS) | 0 |
| Sus. Levofloxacin (BALF) | 18 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 8 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 0 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 5 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 7 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 6 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 5 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 0 |
| Res. Trimethoprim/Sulfamethoxazole (NPS) | 3 |
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| Penicilin (BALF) | 0.50 (0.25 to 16.00) |
| Penicilin (NPS) | 0.5 (0.13 to 16.00) |
| Erythromycin (BALF) | 4.00 (2.00 to 16.00) |
| Erythromycin (NPS) | 4.00 (2.00 to 8.00) |
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole. Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. For the "Unique isolate definition", please refer to the previous outcome description. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| Sus. Amoxicillin/Clavulanate (BALF) | 12 |
| Int. Amoxicillin/Clavulanate (BALF) | 0 |
| Res. Amoxicillin/Clavulanate (BALF) | 1 |
| Sus. Amoxicillin/Clavulanate (NPS) | 9 |
| Int. Amoxicillin/Clavulanate (NPS) | 0 |
| Res. Amoxicillin/Clavulanate (NPS) | 1 |
| Sus. Erythromycin (BALF) | 12 |
| Int. Erythromycin (BALF) | 0 |
| Res. Erythromycin (BALF) | 1 |
| Sus. Erythromycin (NPS) | 9 |
| Int. Erythromycin (NPS) | 0 |
| Res. Erythromycin (NPS) | 1 |
| Sus. Azithromycin (BALF) | 11 |
| Int. Azithromycin (BALF) | 0 |
| Res. Azithromycin (BALF) | 2 |
| Sus. Azithromycin (NPS) | 9 |
| Int. Azithromycin (NPS) | 0 |
| Res. Azithromycin (NPS) | 1 |
| Sus. Tetracycline (BALF) | 13 |
| Int. Tetracycline (BALF) | 0 |
| Res. Tetracycline (BALF) | 0 |
| Sus. Tetracycline (NPS) | 10 |
| Int. Tetracycline (NPS) | 0 |
| Res. Tetracycline (NPS | 0 |
| Sus. Levofloxacin (BALF) | 13 |
| Int. Levofloxacin (BALF) | 0 |
| Res. Levofloxacin (BALF) | 0 |
| Sus. Levofloxacin (NPS) | 10 |
| Int. Levofloxacin (NPS) | 0 |
| Res. Levofloxacin (NPS) | 0 |
| Sus. Trimethoprim/Sulfamethoxazole (BALF) | 7 |
| Int. Trimethoprim/Sulfamethoxazole (BALF) | 5 |
| Res. Trimethoprim/Sulfamethoxazole (BALF) | 1 |
| Sus. Trimethoprim/Sulfamethoxazole (NPS) | 10 |
| Int. Trimethoprim/Sulfamethoxazole (NPS) | 0 |
| Res. Trimethoprim/Sulfamethoxazole (NPS) | 0 |
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| Penicilin (BALF) | 16.00 (0.50 to 16.00) |
| Penicilin (NPS) | 16.00 (1.00 to 16.00) |
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute \[CLSI\] guidelines \[CLSI, 2015\]). Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples. Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
| Unique isolates of subjects | Total Group |
|---|---|
| H. influenzae (BALF) | 3 |
| H. influenzae (NPS) | 1 |
| M. catarrhalis (BALF) | 13 |
| M. catarrhalis (NPS) | 10 |
Demographic characteristics included age, which was expressed in months.
| Months | Total Group |
|---|---|
| Mean Age of Subjects | 39.84 ± 17.76 |
Demographic characteristics included gender: female and male.
| Participants | Total Group |
|---|---|
| Gender (Female) | 92 |
| Gender (Male) | 99 |
Demographic characteristics included weight which was expressed in kilograms (kg).
| Kilograms | Total Group |
|---|---|
| Mean Weight of Subjects | 14.67 ± 3.83 |
Demographic characteristics included height which was expressed in centimeters (cm).
| Centimeters | Total Group |
|---|---|
| Mean Height of Subjects | 96.04 ± 13.10 |
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
| Participants | Total Group |
|---|---|
| BMI - Marked thinness [< z-score (-3)] | 5 |
| BMI - Thinness [≥ z-score (-3) and < z-score (-2)] | 9 |
| BMI - Normal [≥ z-score (-2) and ≤ z-score (1)] | 122 |
| BMI - Overweight [> z-score (1) and ≤ z-score (2)] | 26 |
| BMI - Obesity [> z-score (2) and ≤ z-score (3)] | 14 |
| BMI - Extreme obesity [> z-score (3)] | 4 |
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
| Participants | Total Group |
|---|---|
| Any other pre-existing conditions (Yes) | 176 |
| Any other pre-existing conditions (No) | 15 |
| Congenital chromosomal abnormality (Yes) | 2 |
| Prematurity (<37 weeks) (Yes) | 33 |
| Neonatal problems (Yes) | 18 |
| Chronic renal failure (Yes) | 1 |
| Immune system disorder (Yes) | 1 |
| History of inhaled steroids (Yes) | 134 |
| Atopic dermatitis (Yes) | 49 |
| Clinician-confirmed eczema (Yes) | 4 |
| Asthma (Yes) | 72 |
| Other (Yes) | 117 |
General medical history included mean gestational age.
| Weeks | Total Group |
|---|---|
| Mean Gestational Age of Subjects | 33.00 ± 2.95 |
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
| Participants | Total Group |
|---|---|
| Child has received any PCV (Yes) | 168 |
| Child has received only Prevenar | 15 |
| Child has received only Prevenar 13 | 123 |
| Child has received only Synflorix | 1 |
| Child has received Mix of vaccines | 29 |
| Doses of Prevenar (1) | 2 |
| Doses of Prevenar (2) | 4 |
| Doses of Prevenar (3) | 3 |
| Doses of Prevenar (4) | 6 |
| Doses of Prevenar 13 (1) | 4 |
| Doses of Prevenar 13 (2) | 12 |
| Doses of Prevenar 13 (3) | 46 |
| Doses of Prevenar 13 (4) | 61 |
| Doses of Synflorix (4) | 1 |
| Validated source | 165 |
| Not validated source | 3 |
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
| Participants | Total Group |
|---|---|
| Child has ever received any flu vaccine (Yes) | 58 |
| Number of doses of any flu vaccine (1) | 18 |
| Number of doses of any flu vaccine (2) | 26 |
| Number of doses of any flu vaccine (3) | 6 |
| Number of doses of any flu vaccine (4) | 5 |
| Number of doses of any flu vaccine (5) | 3 |
| Validated source | 52 |
| Not validated source | 6 |
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
| Participants | Total Group |
|---|---|
| Child has received H.I. type b vaccine (Yes) | 188 |
| Number of doses of H.I. type b vaccine (1) | 2 |
| Number of doses of H.I. type b vaccine (2) | 4 |
| Number of doses of H.I. type b vaccine (3) | 38 |
| Number of doses of H.I. type b vaccine (4) | 144 |
| Validated source | 184 |
| Not validated source | 4 |
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
| Participants | Total Group |
|---|---|
| Antibiotic administered in the past 6 months (Yes) | 153 |
| Penicillin | 83 |
| Amoxicillin/ Clavulanate | 76 |
| Cephalosporins | 24 |
| Erythromycin | 1 |
| Azithromycin | 57 |
| Clarithromycin | 8 |
| Ciprofloxacin | 2 |
| Clindamycin | 1 |
| Linezolid | 1 |
| Meropenem | 1 |
| Antibiotics source information. - parent recall | 49 |
| Antibiotics source information. - medical file | 120 |
| Other medications in the past 6 months (Yes) | 177 |
| Source of information. - parent recall | 49 |
| Source of information. - medical file | 149 |
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
| Participants | Total Group |
|---|---|
| Cough (Yes) | 151 |
| Wheezing (Yes) | 86 |
| Pathologic auscultation (Yes) | 74 |
| Infiltrates atelectasis diagnosed by X-ray (Yes) | 131 |
| Wet cough lasting 4 weeks without additional (Yes) | 63 |
| Persistent wheezing lasting 3 months (Yes) | 8 |
| Recurrent wheezing 3 or more episodes/year (Yes) | 25 |
| Persistent pathologic auscultation (Yes) | 16 |
| Persistent 1 month infiltrates atelectasis (Yes) | 65 |
| 3 episodes/year infiltrates atelectasis (Yes) | 14 |
| Any respiratory/otitis media pre-conditions(Yes) | 186 |
| Any respiratory/otitis media pre- conditions (No) | 5 |
| Pneumonia (Yes) | 114 |
| Bronchiolitis (Yes) | 85 |
| Bronchioectasis (Yes) | 15 |
| Bronchitis (Yes) | 143 |
| Rhinitis (Yes) | 15 |
| Acute otitis media (Yes) | 53 |
| Otitis media with effusion or glue ear (Yes) | 6 |
| Otitis media with perforation and discharge (Yes) | 8 |
| The child had ever been breastfed (Yes) | 150 |
| The child had ever been breastfed (No) | 41 |
| The child was currently breastfed (Yes) | 6 |
| The child was currently breastfed (No) | 144 |
| Other children <6 years in the same household (0) | 101 |
| children <6 years in the same household (1-2) | 87 |
| children <6 years in the same household (≥3) | 3 |
| children ≥ 6 years in the same household (0) | 134 |
| children ≥ 6 years in the same household (1-2) | 55 |
| children ≥ 6 years in the same household (≥3) | 2 |
| Child at daycare &/school at least 2 day/week(Yes) | 155 |
| Child at day care &/school at least 2 day/week(No) | 36 |
| Child lived within 1 km of major polluters (Yes) | 63 |
| Child lived within 1 km of major polluters (No) | 128 |
| Major roadway (Yes) | 20 |
| Highway (Yes) | 27 |
| Area where trucks or vehicles were idle (Yes) | 11 |
| Major industry area with smokestacks (Yes) | 13 |
| Other (Yes) | 6 |
| Child with>3 day/week to cigarette smoke(Yes) | 38 |
| Child with>3 day/ week to cigarette smoked (No) | 153 |
| Previous episodes within the last year (0) | 2 |
| Previous episodes within the last year (1) | 11 |
| Previous episodes within the last year (2-3) | 52 |
| Previous episodes within the last year (4-5) | 45 |
| Previous episodes within the last year (6 or more) | 73 |
| Cough productive or wet (Yes) | 153 |
| Cough paroxysmal (Yes) | 29 |
| Cough laryngeal (Yes) | 38 |
| Shortness of breath independent of coughing (Yes) | 35 |
| Shortness of breath secondary to cough (Yes) | 33 |
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC \[LRTI-WBC\], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP \[LRTI-CRP\], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR \[LRTI-ESR\].
| Participants | Total Group |
|---|---|
| Blood sample results available (Yes) | 109 |
| WBC count analysed (Yes) | 109 |
| WBC reference range (low-high ranges) | 78 |
| WBC reference range (>high range) | 31 |
| LRTI-WBC (Yes) | 18 |
| LRTI-WBC (No) | 17 |
| CRP analysed (Yes) | 57 |
| CRP analysed (No) | 52 |
| CRP reference range (low-high ranges) | 26 |
| CRP reference range (>high range) | 31 |
| CRP reference range (missing range) | 52 |
| CRP groups <40 mg/L | 46 |
| CRP groups ≥40-80 mg/L | 6 |
| CRP groups ≥80-120 mg/L | 3 |
| CRP groups ≥120 mg/L | 2 |
| LRTI-CRP (Yes) | 17 |
| LRTI-CRP (No) | 17 |
| ESR analysed (Yes) | 12 |
| ESR analysed (No) | 97 |
| ESR reference range (low-high ranges) | 8 |
| ESR reference range (>high range) | 4 |
| ESR reference range (missing range) | 97 |
| LRTI-ESR (Yes) | 2 |
| LRTI-ESR (No) | 3 |
Laboratory results for WBC were expressed in 10\^9 cells per liter (10\^9 cells/L).
| 10^9 cells/L | Total Group |
|---|---|
| White Blood Cells (WBC) Laboratory Results | 540.17 ± 2651.17 |
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
| mg/L | Total Group |
|---|---|
| C-reactive Protein (CRP) Laboratory Results | 25.45 ± 37.91 |
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
| mm/hr | Total Group |
|---|---|
| Erythrocyte Sedimentation Rate (ESR) Laboratory Results | 25.33 ± 30.67 |
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
| Participants | Total Group |
|---|---|
| A Chest X-ray was done (Yes) | 166 |
| A Chest X-ray was done (No) | 25 |
| Result (Normal) | 23 |
| Result (Abnormal) | 143 |
| Abnormality relevant to collecting the BALF(Yes) | 122 |
| Abnormality relevant to collecting the BALF (No) | 21 |
Collected over SAE(s) considered related to the nasopharyngeal sampling procedure were reported during the entire study period, which lasted 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Group | 0/197 (0%) | 0/197 (0%) | — |
| Age, Continuous(Months) | Total Group |
|---|---|
| Mean | 40.7 ± 18.2 |
| Sex: Female, Male(Participants) | Total Group |
|---|---|
| Female | 95 |
| Male | 102 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2013 to primary completion in Sep 2015, 24 months.
Results were first posted in Oct 2019, 4 years after primary completion.
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