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Status unknownNCT04283422Updated Feb 25, 2020

Diagnosis of Lower Respiratory Tract Infections Using Biofire Filmarray

An observational study in Biofire Filmarray, sponsored by Assiut University. Status unknown. Open to participants aged 10 Days to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
10 Days to 18 Years
Sex
All
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Study summary

Comparison of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit using biofire filmarray and vitek2

  • Antibiotic sensitivity using vitek2
  • Comparison of the type of antibiotic resistance using biofire filmarray and vitek2
  • To provide information about prevalence of these organisms.
Read the detailed description

Acute respiratory infections (ARI) are a leading cause of morbidity and mortality worldwide. Although usually more severe in children, the elderly and immunocompromised patients, all populations and age groups are susceptible.

Lower respiratory infections are the third leading cause of death worldwide and nearly two million childhood deaths worldwide are attributable to ARI, with the vast majority occurring in developing countries.The World Health Organization estimates that in 2013, over 8% of all deaths in the Eastern Mediterranean Region were attributable to ARIs. However, regional data on morbidity and etiology of these infections are lacking.

These infections have a significant impact on antimicrobial prescriptions, hospitalizations and lost time from work and school. The most frequent agents responsible for ARI are respiratory viruses followed by bacteria .Empiric treatment with antibiotics is frequently initiated even when viral infection is a strong possibility,leading to unnecessary antibiotic use . The early diagnosis of the pathogen is beneficial for the precise selection of medication,which can largely avoid the overuse or even abuse of the antibiotics and improve the clinical care of patients. More importantly, the early diagnosis of contagious pathogens, such as Bordetella pertussis (B. pertussis) and influenza viruses, can enable early isolation of patients, thus reducing the spread of pathogens.

At present, the routine detection methods for respiratory pathogens are mostly based on immunological methods.

Direct diagnosis of respiratory viruses by antigen detection using immunofluorescence assays (IFA), is still used but is typically limited to eight viruses (adenovirus [AdV], influenza A [FluA], influenza B [FluB], parainfluenza [PIV], human metapneumovirus [HMPV] and respiratory syncytial virus [RSV]) and may lack sensitivity depending on the viral titer, patient´s age and time of testing in relation to the onset of symptoms .

Molecular methods such as Polymerase chain reaction (PCR) increase viral detection due to a greater analytic sensitivity compared to conventional methods such as antigen detection and/or viral culture.

Microbiological analysis and identification of organisms may take 48-72 h,false negative results may occur as a result of concomitant or previous antibiotic treatment , whereas false positive may represent colonization or sampling errors.

The VITEK 2 is a fully automated system for microbial identification and antimicrobial susceptibility testing (AST ), after a primary inoculums has been prepared and standardized . With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods.(6) The application of FilmArray respiratory panel in the diagnosis of lower respiratory tract infections is designed to reduce the time for identification of the microorganisms FilmArray is a small, desktop, fully automated multiplex PCR device. The molecular system includes automated nucleic acid extraction, an initial reverse transcription step and multiplex nested PCR, followed by a melting curve analysis .

The BIOFIRE® FILMARRAY® Pneumonia Panel plus tests for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other lower respiratory tract infections. It offers an overall sensitivity and specificity for bronchoalveolar (BAL)-like samples of 96,2% and 98.3%, respectively, and for sputum samples a sensitivity and specificity of 96.3% and 97.2%, respectively.The test is performed in a closed system that requires 5 min of hands-on time and 65 min of instrumentation time. Several comparison studies between FilmArray and other tests for respiratory organisms showed comparable results .

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Conditions studied

  • Biofire Filmarray
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In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 60 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients with acute lower respiratory tract infections.

Inclusion criteria

  • Pediatric patients with acute lower respiratory tract infections.

Exclusion criteria

Exclusion Criteria:

  • Age above 18 years old
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • patintes on mechanical ventilation

    Diagnostic Test: Biofire filmarray

  • patintes not on mechanical ventilation

    Diagnostic Test: Biofire filmarray

Interventions

  • Diagnostic testBiofire filmarray

    Identification of microorganisms including: 1. Isolation of microorganisms: The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates, 2. Identification of the organism by Vitek2 3. Antibiotic sensitivity test of the organism by Vitek2 4. Identification of the organism by Biofire filmarray

    Also known as: Vitek2

06

What researchers measure

Primary outcomes

  1. Percentage of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit

    Percentage of pathogens including viruses ,bacteria and fungi responsible for lower respiratory tract infections will be carried out by using biofire Filmarray and vitek 2

    Time frame: one year

  2. Prevalence of drug resistance in bacteria

    Gene of drug resistance in bacteria will be detected by using biofire Filmarray and phenotypic tests by using vitk2 vitek2

    Time frame: one year

  3. prevalence of pathogens causing lower respiratory tract infections .

    prevalence of both bacterial and fungal infection causing lower respiratory tract infections by vitek2

    Time frame: one year

Secondary outcomes

  1. Rapid identification of causative organisms in critical cases.

    Rapid identification of causative organisms in critical cases bu using the biofire filmarray

    Time frame: one hour

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Rowlinson E, Dueger E, Mansour A, Azzazy N, Mansour H, Peters L, Rosenstock S, Hamid S, Said MM, Geneidy M, Abd Allah M, Kandeel A. Incidence and etiology of hospitalized acute respiratory infections in the Egyptian Delta. Influenza Other Respir Viruses. 2017 Jan;11(1):23-32. doi: 10.1111/irv.12409. Epub 2016 Aug 12. PubMed 27458989 ↗
  • Li J, Tao Y, Tang M, Du B, Xia Y, Mo X, Cao Q. Rapid detection of respiratory organisms with the FilmArray respiratory panel in a large children's hospital in China. BMC Infect Dis. 2018 Oct 11;18(1):510. doi: 10.1186/s12879-018-3429-6. PubMed 30305033 ↗
  • Chun K, Syndergaard C, Damas C, Trubey R, Mukindaraj A, Qian S, Jin X, Breslow S, Niemz A. Sepsis Pathogen Identification. J Lab Autom. 2015 Oct;20(5):539-61. doi: 10.1177/2211068214567345. Epub 2015 Jan 28. PubMed 25631157 ↗
  • Wahrenbrock MG, Matushek S, Boonlayangoor S, Tesic V, Beavis KG, Charnot-Katsikas A. Comparison of Cepheid Xpert Flu/RSV XC and BioFire FilmArray for Detection of Influenza A, Influenza B, and Respiratory Syncytial Virus. J Clin Microbiol. 2016 Jul;54(7):1902-1903. doi: 10.1128/JCM.00084-16. Epub 2016 Apr 20. PubMed 27098956 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04283422
Lead sponsor
Assiut University
Responsible party
Alaa Kadry Moawad (assistant lecturer, Assiut University) — Principal investigator
First posted
Feb 25, 2020
Start date
Mar 1, 2020 (estimated)
Primary completion
Mar 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Feb 25, 2020

Study contacts

alaa K moawad, assistant lecturer
Contact
alaakadryanoo@gmail.com
+201007413933
Amal M Hosni, lecturer
Contact
amal.alameldin@yahoo.com
+201026122444

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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