Biofire FilmarrayNCT04283422
Diagnosis of Lower Respiratory Tract Infections Using Biofire Filmarray
An observational study of Biofire Filmarray, run by Assiut University.
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.
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 .
- Conditions
- Biofire Filmarray
- 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:
- Isolation of microorganisms: The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates,
- Identification of the organism by Vitek2
- Antibiotic sensitivity test of the organism by Vitek2
- Identification of the organism by Biofire filmarray
| Study group | Role | What they receive |
|---|---|---|
| patintes on mechanical ventilation | Not described Receives: Diagnostic Test: Biofire filmarray | |
| patintes not on mechanical ventilation | Not described Receives: Diagnostic Test: Biofire filmarray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Biofire FilmarrayStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Kadry Moawad, Assiut University
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 27458989Li 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 30305033Chun 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 25631157Wahrenbrock 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Lower Respiratory Tract Infections in Pediatric Patients in Intensive Care Unit Using Biofire Filmarray
- ClinicalTrials.gov ID
- NCT04283422
- Acronym / sponsor ID
- Biofire filmarray in LRTI
- Conditions
- Biofire Filmarray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patintes on mechanical ventilation | – | Diagnostic Test: Biofire filmarray |
| patintes not on mechanical ventilation | – | Diagnostic Test: Biofire filmarray |
Who may qualify
- Ages
- 10 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with acute lower respiratory tract infections.
Key inclusion criteria (1 listed)
- Pediatric patients with acute lower respiratory tract infections.
Key exclusion criteria (1 listed)
- Age above 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofire filmarrayAlso: Vitek2Identification 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 | Diagnostic test | patintes not on mechanical ventilation, patintes on mechanical ventilation |
Primary outcome
Percentage of pathogens causing lower respiratory tract infections in ventilated versus non ventilated pediatric patients in intensive care unit
Time frame: one year
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
Prevalence of drug resistance in bacteria
Time frame: one year
Gene of drug resistance in bacteria will be detected by using biofire Filmarray and phenotypic tests by using vitk2 vitek2
prevalence of pathogens causing lower respiratory tract infections .
Time frame: one year
prevalence of both bacterial and fungal infection causing lower respiratory tract infections by vitek2
1 secondary outcome
Rapid identification of causative organisms in critical cases.
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 27458989Rowlinson 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.
- Background: PubMed 30305033Li 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.
- Background: PubMed 25631157Chun 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.
- Background: PubMed 27098956Wahrenbrock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.