An interventional study of Blood sampling and Stool sample collection in Infections, Clostridium Difficile, sponsored by GlaxoSmithKline. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Basic science
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Among 121 studies in Clostridium Infections with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Clostridium Infections · United States.
Among the 121 studies in Clostridium Infections with a site in United States, this one is the 51st largest by enrollment of the 102 interventional ones that give a count, is one of 9 that started in 2013, is one of 14 with no phase, and was the 18th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →16 of the 121 studies in Clostridium Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Healthy volunteers
Acurx Pharmaceuticals Inc. · Sites in United States
Ages 18–90
Medical College of Wisconsin · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 40 · Phase 3 21 · Phase 4 14
First in 1998; this study’s year is marked. 9 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is below the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Median enrollment 57 across the 102 interventional studies, 132 across the 19 observational. Of the 91 that completed or were terminated, 52 (57%) have results posted.
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48 of 121 have an industry lead sponsor. The 10 most frequent:
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.
GlaxoSmithKline has 2 studies filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Clostridium Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT04305769University of VirginiaAlanyl-glutamine Supplementation for C. Difficile Treatment (ACT) | 2026-12-31 |
| NCT07250724Bactolife A/SC. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI. | 2027-01-15 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
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Among the 121 studies in Clostridium Infections with a site in United States, from their registry updates:
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This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
Patients with an initial episode of CDI will be followed up for CDI recurrence or sustained clinical response. The subjects will be allocated into 2 groups at the study end:
This protocol has been amended twice to improve recruitment of subjects in the study.
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Exclusion Criteria:
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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.
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.
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.
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.
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.
Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
Procedure: Blood sampling · Other: Stool sample collection
Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
Procedure: Blood sampling · Other: Stool sample collection
Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
Procedure: Blood sampling · Other: Stool sample collection
Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
Procedure: Blood sampling · Other: Stool sample collection
Blood sampling will be done at Day 0, at Day 14, at recurrence (if applicable) and at end of follow-up.
Stool samples will be collected around Day 0, around Day 14 and at recurrence (if applicable).
Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14
Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL.
Time frame: At Day 14
Serum F2 C-terminal Anti-toxin B Antibody Concentrations
Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL.
Time frame: At Day 14
Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72
Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off equal to or above (≥) 100 EU/mL.
Time frame: At Day 0 and at Day 72
Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14
Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization.
Time frame: At Day 14
Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 0, Within 10 Days After Recurrence and at Day 72
Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization. This measure concerned only diarrhea recurrence. No CDI recurrence was considered as part of the Group Sustained Response.
Time frame: At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (Day 72)
Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence
A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode.
Time frame: From Day 0 to Day 72
CDI Initial Episodes Severity Characteristics, in All Subjects
Severity characteristics were expressed in duration of days for hospitalization, intensive care unit, Standard of Care (SoC) and CDI episodes.
Time frame: At Day 0
Number of Subjects With Initial CDI Episode by Severity, in All Subjects
Initial CDI episodes were recorded by severity criteria: medical attention given, admission to intensive care unit, colectomy, death, high white blood cells (WBC) count, high creatinine count, hypotension/shock, clinical response to Standard of Care (SoC).
Time frame: At Day 0
Number of Subjects With CDI Recurrence by Severity, in Those Subjects Who Recur
A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode. An episode of diarrhea was not considered as a recurrence of CDI if the stool was negative for C. difficile or if the diarrhea was attributed to another cause than C. difficile. The severity criteria for CDI recurrent episodes were categorized into non-severe and severe.
Time frame: At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant
Number of Subjects With Failure of Antibiotic Treatment
Failure of antibiotic treatment against C. difficile is defined as the persistence or the incomplete resolution of symptoms (more than one unformed stool per day) after a full course of antibiotic(s) therapy (minimum 7 days). Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin. Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone. Aminopen+BetaLactam Inhib and Fluoroquinolone = Aminopenicillin+Beta-Lactamase Inhibitor and Fluoroquinolone. Antipseudom Pen+BetaLactam Inhib and Cephalosporin = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone and Glycopeptides (Iv). Antipseudom Pen+BetaLactam Inhib and Glycopeptides = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and Glycopeptides (Iv).
Time frame: Within 3 months before the initial CDI episodes
Number of Subjects With Risk Factors Associated With the Initial CDI Episode
Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures). CDI episodes within 6 months: Protocol exclusion criteria for enrolment allowed up to maximum 25% of the planned subjects having a previous CDI episode within the previous 6 months. Antibiotic taken within 3 months: Antibiotic not prescribed to treat C. difficile taken within 3 months before the current CDI episode.
Time frame: At Day 0
Number of Subjects With Risk Factors Associated With the CDI Recurrence
Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures).
Time frame: At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant
In total 57 subjects were enrolled, among which 11 subjects from one centre in the United States (University of Texas School of Public Health, Houston) who were excluded from final analysis due to GCP issues.
| Milestone | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Started | 7 | 25 | 5 | 9 |
| Completed | 7 | 25 | 0 | 1 |
| Not completed | 0 | 0 | 5 | 8 |
| Withdrew: Failure of antibiotic treatment to treat | 0 | 0 | 5 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 5 |
| Withdrew: Death | 0 | 0 | 0 | 2 |
| Withdrew: Immunosuppressants>14days past 6months | 0 | 0 | 0 | 1 |
Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL.
| EU/mL | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14 | 2083.3 (995.8 to 4358.5) | 3189.4 (1338.4 to 7600.2) | — | 32096.4 (26.1 to 39518495) |
Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL.
| EU/mL | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Serum F2 C-terminal Anti-toxin B Antibody Concentrations | 149.3 (20.2 to 1102.9) | 246.6 (52.7 to 1154.8) | — | 10736.7 (1.7 to 69276208) |
Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off equal to or above (≥) 100 EU/mL.
| EU/mL | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Anti-toxin B at Day 0 | 1939.6 (847.2 to 4440.6) | 1682.9 (858.7 to 3298.2) | — | 19638.5 (217.5 to 1773406) |
| Anti-toxin B at Day 72 | 4471.1 (1441.1 to 13871.8) | 3670.4 (1519.8 to 8864.6) | — | 64050.6 (NA to NA) |
Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization.
| Titer | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Neutralizing anti-toxin A | 11.3 (0.7 to 194.8) | 2.3 (1.2 to 4.5) | — | 4.7 (0.0 to 1584000000) |
| Neutralizing anti-toxin B | 2.7 (0.4 to 18.2) | 15.3 (4.2 to 55.1) | — | 1725.7 (125.5 to 23728.0) |
Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization. This measure concerned only diarrhea recurrence. No CDI recurrence was considered as part of the Group Sustained Response.
| Titer | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Neutralizing anti-toxin A, Day 0 | 14.8 (0.4 to 525.0) | 1.5 (0.9 to 2.4) | — | 3.2 (0.0 to 7130211) |
| Neutralizing anti-toxin A, recurrence 1 | 12.2 (0.6 to 241.2) | 1.0 (NA to NA) | — | — |
| Neutralizing anti-toxin A, recurrence 2 | 1.0 (NA to NA) | — | — | — |
| Neutralizing anti-toxin A, Day 72 | 11.1 (0.3 to 422.0) | 2.5 (1.2 to 5.4) | — | — |
| Neutralizing anti-toxin B, Day 0 | 3.3 (0.4 to 28.0) | 9.6 (2.7 to 34.1) | — | 340.3 (0.0 to 461890000) |
| Neutralizing anti-toxin B, recurrence 1 | 3.0 (0.4 to 22.3) | 1.0 (NA to NA) | — | — |
| Neutralizing anti-toxin B, recurrence 2 | 1.0 (NA to NA) | — | — | — |
| Neutralizing anti-toxin B, Day 72 | 8.0 (1.1 to 56.8) | 16.2 (4.3 to 60.3) | — | 1372.0 (NA to NA) |
A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode.
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence | 7 | 0 | 0 | 0 |
Severity characteristics were expressed in duration of days for hospitalization, intensive care unit, Standard of Care (SoC) and CDI episodes.
| Days | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Duration of hospitalization | — | 5.0 (4.0 to 11.0) | 7.0 (7.0 to 7.0) | 16.0 (8.0 to 22.0) |
| Duration in intensive care unit | — | 5.0 (4.0 to 6.0) | — | 8.0 (7.0 to 17.0) |
| Duration of CDI episodes | 10.5 (9.0 to 15.0) | 6.0 (4.0 to 13.0) | 24.0 (14.5 to 33.5) | 10.0 (5.0 to 15.0) |
| Duration of SoC | 11.0 (11.0 to 15.0) | 14.0 (11.0 to 16.0) | 34.0 (11.0 to 84.0) | 11.0 (10.0 to 26.0) |
Initial CDI episodes were recorded by severity criteria: medical attention given, admission to intensive care unit, colectomy, death, high white blood cells (WBC) count, high creatinine count, hypotension/shock, clinical response to Standard of Care (SoC).
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Medical attention - Medical contact without visit | 1 | 1 | 1 | 0 |
| Medical attention - Medical personnel visit | 2 | 3 | 1 | 0 |
| Medical attention - Emergency Room | 2 | 6 | 1 | 1 |
| Medical attention - Hospitalization | 2 | 15 | 2 | 8 |
| Intensive care unit - Yes | 0 | 3 | 0 | 3 |
| Intensive care unit - No | 7 | 22 | 5 | 6 |
| Colectomy - Yes | 0 | 0 | 0 | 0 |
| Colectomy - No | 7 | 25 | 5 | 9 |
| Death - Yes | 0 | 0 | 0 | 0 |
| Death - No | 7 | 25 | 5 | 9 |
| Non-severe CDI episode | 7 | 23 | 5 | 6 |
| Severe CDI episode | 0 | 2 | 0 | 3 |
| Leukocytosis with high WBC count | 0 | 1 | 0 | 1 |
| Serum creatinine high level | 0 | 0 | 0 | 1 |
| Hypotension/shock | 0 | 0 | 0 | 1 |
| Leukocytosis with high WBC count+Hypotension/shock | 0 | 1 | 0 | 0 |
| Clinical response at end of SoC - Yes | 6 | 18 | 0 | 1 |
| Clinical response at end of SoC - No | 1 | 4 | 2 | 1 |
| Clinical response at end of SoC - Unspecified | 0 | 3 | 3 | 7 |
| Detection of C. difficile strains - Yes | 1 | 2 | 0 | 1 |
| Detection of C. difficile strains - No | 6 | 23 | 5 | 5 |
| Stool not collected or discarded - CDI detection | 0 | 0 | 0 | 3 |
A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode. An episode of diarrhea was not considered as a recurrence of CDI if the stool was negative for C. difficile or if the diarrhea was attributed to another cause than C. difficile. The severity criteria for CDI recurrent episodes were categorized into non-severe and severe.
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Non-severe | 7 | — | — | — |
| Severe | 0 | — | — | — |
Failure of antibiotic treatment against C. difficile is defined as the persistence or the incomplete resolution of symptoms (more than one unformed stool per day) after a full course of antibiotic(s) therapy (minimum 7 days). Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin. Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone. Aminopen+BetaLactam Inhib and Fluoroquinolone = Aminopenicillin+Beta-Lactamase Inhibitor and Fluoroquinolone. Antipseudom Pen+BetaLactam Inhib and Cephalosporin = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone and Glycopeptides (Iv). Antipseudom Pen+BetaLactam Inhib and Glycopeptides = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and Glycopeptides (Iv).
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| 1st Generation Cephalosporin | 0 | 2 | 1 | 0 |
| 1st Gen Cephalosporin+Tetracyclin, no Tigecyclin | 1 | 0 | 0 | 0 |
| 3rd Generation Cephalosporin, no Ceftazidime | 0 | 1 | 0 | 0 |
| 4th Generation Cephalosporin and Fluoroquinolone | 0 | 1 | 0 | 0 |
| Aminopenicillin | 0 | 3 | 0 | 0 |
| Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin | 1 | 0 | 0 | 0 |
| Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin | 1 | 0 | 0 | 0 |
| Aminopen+BetaLactam Inhib and Fluoroquinolone | 0 | 0 | 0 | 1 |
| Aminopenicillin And Macrolide | 0 | 1 | 0 | 0 |
| Antipseudom Pen+BetaLactam Inhib and Cephalosporin | 0 | 0 | 0 | 1 |
| Antipseudom Pen+BetaLactam Inhib and Glycopeptides | 0 | 0 | 0 | 1 |
| Fluoroquinolone | 0 | 1 | 1 | 1 |
| Fluoroquinolone And 3rd/4th Gen Fluoroquinolone | 0 | 1 | 0 | 0 |
| Fluoroquinolone And Lincosamide | 0 | 1 | 0 | 0 |
| Glycopeptides (Iv) | 0 | 1 | 0 | 1 |
| Lincosamide | 2 | 1 | 0 | 0 |
| Macrolide | 0 | 1 | 0 | 0 |
| Metronidazole and Aminopenicillin | 0 | 1 | 0 | 0 |
| Metronidazole and Fluoroquinolone and Lincosamide | 1 | 0 | 0 | 0 |
| Monobactam And Fluoroquinolone | 0 | 1 | 0 | 0 |
| Rifamycin | 0 | 1 | 0 | 1 |
| Subject Does Not Recall Name Of Abx | 0 | 1 | 0 | 0 |
Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures). CDI episodes within 6 months: Protocol exclusion criteria for enrolment allowed up to maximum 25% of the planned subjects having a previous CDI episode within the previous 6 months. Antibiotic taken within 3 months: Antibiotic not prescribed to treat C. difficile taken within 3 months before the current CDI episode.
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Setting of CDI development: Community | 5 | 18 | 3 | 2 |
| Setting of CDI development: Hospital | 2 | 6 | 1 | 6 |
| Setting of CDI development: Nursing home | 0 | 0 | 0 | 0 |
| Setting of CDI development: Rehabilitation center | 0 | 0 | 0 | 0 |
| Setting of CDI development: Other | 0 | 1 | 1 | 1 |
| No CDI episodes within 6 months | 6 | 22 | 4 | 8 |
| CDI episodes within 6 months | 1 | 3 | 1 | 1 |
| No admission to hospital within 3 months | 6 | 15 | 4 | 4 |
| Admission to hospital within 3 months | 1 | 10 | 1 | 5 |
| Not staying in nursing home within 3 months | 7 | 25 | 5 | 8 |
| Staying in nursing home within 3 months | 0 | 0 | 0 | 1 |
| Not staying in rehabilitation center within 3 mths | 7 | 25 | 5 | 8 |
| Staying in rehabilitation center within 3 months | 0 | 0 | 0 | 1 |
| No antibiotic taken within 3 months | 1 | 7 | 3 | 3 |
| Antibiotic taken within 3 months | 6 | 18 | 2 | 6 |
| No proton Pump Inhibitors taken within 3 months | 2 | 18 | 0 | 4 |
| Proton Pump Inhibitors taken within 3 months | 5 | 7 | 5 | 5 |
| No anti-acid drugs taken within 3 months | 3 | 24 | 4 | 7 |
| Anti-acid drugs taken within 3 months | 4 | 1 | 1 | 2 |
| No nutrition via feeding tube within 3 months | 7 | 25 | 5 | 9 |
| Nutrition via feeding tube within 3 months | 0 | 0 | 0 | 0 |
Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures).
| Participants | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group |
|---|---|---|---|---|
| Setting of CDI development: Community | 6 | — | — | — |
| Setting of CDI development: Hospital | 1 | — | — | — |
| Setting of CDI development: Nursing home | 0 | — | — | — |
| Setting of CDI development: Rehabilitation center | 0 | 0 | — | — |
| Setting of CDI development: Other | 0 | — | — | — |
| No admission to hospital during follow-up period | 7 | — | — | — |
| Admission to hospital during follow-up period | 0 | — | — | — |
| Not staying in nursing home during FU period | 7 | — | — | — |
| Staying in nursing home during follow-up period | 0 | — | — | — |
| Not staying in rehab. center during FU period | 7 | — | — | — |
| Staying in rehabilitation center during FU period | 0 | — | — | — |
| No antibiotic taken during FU period | 5 | — | — | — |
| Antibiotic taken during FU period | 2 | — | — | — |
| No Proton Pump Inhibitors taken during FU period | 4 | — | — | — |
| Proton Pump Inhibitors taken during FU period | 3 | — | — | — |
| No anti-acid drugs taken during FU period | 6 | — | — | — |
| Anti-acid drugs taken during FU period | 1 | — | — | — |
| No nutrition via feeding tube during FU period | 7 | — | — | — |
| Nutrition via feeding tube during FU period | 0 | — | — | — |
Collected over Serious adverse events related to study participation or to a concurrent GSK medication/vaccine were collected during the entire study period (from Day 0 to Day 72).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recurrence Group | 0/7 (0%) | 0/7 (0%) | — |
| Sustained Response Group | 0/25 (0%) | 0/25 (0%) | — |
| Failure to Antibiotic Group | 0/5 (0%) | 0/5 (0%) | — |
| Unclassified Group | 2/9 (22.2%) | 0/9 (0%) | — |
| Age, Continuous(Years) | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group | Total |
|---|---|---|---|---|---|
| Mean | 47.1 ± 18.3 | 53.5 ± 20.1 | 58.0 ± 12.0 | 64.0 ± 18.0 | 55.1 ± 18.9 |
| Sex: Female, Male(Participants) | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group | Total |
|---|---|---|---|---|---|
| Female | 3 | 16 | 2 | 4 | 25 |
| Male | 4 | 9 | 3 | 5 | 21 |
| Race/Ethnicity, Customized(Participants) | Recurrence Group | Sustained Response Group | Failure to Antibiotic Group | Unclassified Group | Total |
|---|---|---|---|---|---|
| African Heritage / African American | 0 | 4 | 3 | 4 | 11 |
| Asian - Japanese Heritage | 0 | 1 | 0 | 0 | 1 |
| Asian - South East Asian Heritage | 0 | 0 | 0 | 1 | 1 |
| White - Caucasian / European Heritage | 7 | 18 | 2 | 4 | 31 |
| Unspecified | 0 | 2 | 0 | 0 | 2 |
Ran from Feb 2013 to primary completion in Jun 2015, 27 months.
Results were first posted in Jun 2019, 4 years after primary completion.
Of 27 interventional studies with no phase under Clostridium Infections, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
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