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Biofire FilmarrayNCT04283422

Diagnosis of Lower Respiratory Tract Infections Using Biofire Filmarray

An observational study of Biofire Filmarray, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 days to 18 years
Conditions the study is for
Biofire Filmarray
What is being tested?
Biofire filmarray
How many people
60 participants
Where
No sites listed yet
Study dates
1 Mar 2020to Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Pediatric patients with acute lower respiratory tract infections.

Who may be able to join

  • Pediatric patients with acute lower respiratory tract infections.

Who cannot join

  • Age above 18 years old

Trial locations and contacts

No sites are listed yet.

alaa K moawad, assistant lecturer contact

+201007413933

alaakadryanoo@gmail.com

Amal M Hosni, lecturer contact

+201026122444

amal.alameldin@yahoo.com

About this study

Official title: Diagnosis of Lower Respiratory Tract Infections in Pediatric Patients in Intensive Care Unit Using Biofire Filmarray

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 .

Being tested
Biofire filmarray

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biofire filmarrayDiagnostic test

    Also called Vitek2

    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
Study groups in NCT04283422
Study groupRoleWhat they receive
patintes on mechanical ventilationNot described
Receives: Diagnostic Test: Biofire filmarray
patintes not on mechanical ventilationNot described
Receives: Diagnostic Test: Biofire filmarray

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: one year

Secondary outcomes (1)
  1. Rapid identification of causative organisms in critical cases.

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

    Measured: one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04283422
Sponsor's protocol ID
Biofire filmarray in LRTI
Status last verified
Feb 2020
First submitted
20 Feb 2020
Last updated
25 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Biofire Filmarray, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact alaa K moawad, assistant lecturer (+201007413933, alaakadryanoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04283422, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.

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