Ebola Virus DiseaseNCT02658331
Evaluation of the FilmArray BioThreat-E Test
An observational study of Ebola Virus Disease, run by BioMérieux.
Trial summary
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ebola Virus Disease
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of Ebola Virus Disease according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
Who may be able to join
- All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of EVD according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
- Ability to deliver a written informed consent
Who cannot join
- Age below 18.
- Inability to provide a consent
- Inability to provide the blood specimens required for Ebola virus disease diagnosis.
About this study
Official title: Clinical Evaluation of the BioFire FilmArray® BioThreat-E Test for the Diagnosis of Ebola Virus Disease in West Africa
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.
Read the detailed description
The study will be conducted at the "Laboratoire des Fièvres Hémorragiques Virales" in Donka National Hospital (Conakry, Guinea), which is the Reference Laboratory for Hemorrhagic Fevers in Guinea. The reference based population includes the regions of Conakry and Coyah. No specific invasive intervention is required for this research protocol and the study does not interfere with the management of the patients according to the ongoing practices in Donka Ebola Treatment Center and in Coyah Ebola Treatment Center. Each participant will be verbally informed before signing an informed consent. Clinical data will be collected and recorded via a source document questionnaire - Clinical Report Form - based on the routine clinical data already provided to the laboratory according to the practices. Another questionnaire will be submitted to the biologist and technicians involved in the study to assess the practicability of the FilmArray technology, compared to conventional techniques, in terms of time to results, duration of test manipulation, sense of personnel safety for specimen handling, overall workload after each day, and preference of lab professionals.
As the main objective, analytical performance (sensitivity and specificity) and clinical performance (positive and negative predictive values) of the FA BioThreat-E test in whole blood will be evaluated in comparison with the QuantiTect® Probe RT-PCR (Qiagen) and the RealStar® Filovirus Type RT-PCR Kit 1.0 (Altona) both tests performed on serum.
The status for EVD will be defined for each patient based on the result of routine testing:
- Positive patients: patients enrolled in the study showing positive results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Negative patients: patients enrolled in the study showing negative results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Equivocal patients: all other results showing a discrepancy between the two routine tests.
As a secondary objective, the possibility of using the FilmArray (FA) BioThreat-E test on non-invasive specimens will also be assessed. Urine and saliva specimens will be analyzed by FA for confirmed positive cases only (based on routine testing), for patients able to provide saliva and/or urine specimens according to their health condition.
This research protocol was approved by the Guinean Ethical Committee.
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola Virus Disease, Rapid Diagnosis, Point of care, Molecular platform
- Medical subject headings
- Hemorrhagic Fever, Ebola
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood.
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test in comparision with their Ebola Virus Disease status as defined based on the result of routine testing.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (2)
Number of urine specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a urine specimen.
Measured: Through study completion, an average of 6 months.
Number of saliva specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a saliva specimen.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fondation Mérieux, Donka University Hospital, Conakry
- Responsible party
- Sponsor
- Investigators
- Françoise Gay-Andrieu, MD-PhD, Study chair, BioMérieuxN'Fally Magassouba, PhD, Principal investigator, Laboratoire des Fièvres Hémorragiques en Guinée - Université Gamal Nasser, Conakry.Mark Miller, MD-FRCPC, Study director, BioMérieux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658331
- Sponsor's protocol ID
- EbolaFire
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Leski TA, Ansumana R, Taitt CR, Lamin JM, Bangura U, Lahai J, Mbayo G, Kanneh MB, Bawo B, Bockarie AS, Scullion M, Phillips CL, Horner CP, Jacobsen KH, Stenger DA. Use of the FilmArray System for Detection of Zaire ebolavirus in a Small Hospital in Bo, Sierra Leone. J Clin Microbiol. 2015 Jul;53(7):2368-70. doi: 10.1128/JCM.00527-15. Epub 2015 May 13.
PubMed 25972415Southern TR, Racsa LD, Albarino CG, Fey PD, Hinrichs SH, Murphy CN, Herrera VL, Sambol AR, Hill CE, Ryan EL, Kraft CS, Campbell S, Sealy TK, Schuh A, Ritchie JC, Lyon GM 3rd, Mehta AK, Varkey JB, Ribner BS, Brantly KP, Stroher U, Iwen PC, Burd EM. Comparison of FilmArray and Quantitative Real-Time Reverse Transcriptase PCR for Detection of Zaire Ebolavirus from Contrived and Clinical Specimens. J Clin Microbiol. 2015 Sep;53(9):2956-60. doi: 10.1128/JCM.01317-15. Epub 2015 Jul 8.
PubMed 26157148Weller SA, Bailey D, Matthews S, Lumley S, Sweed A, Ready D, Eltringham G, Richards J, Vipond R, Lukaszewski R, Payne PM, Aarons E, Simpson AJ, Hutley EJ, Brooks T. Evaluation of the Biofire FilmArray BioThreat-E Test (v2.5) for Rapid Identification of Ebola Virus Disease in Heat-Treated Blood Samples Obtained in Sierra Leone and the United Kingdom. J Clin Microbiol. 2016 Jan;54(1):114-9. doi: 10.1128/JCM.02287-15. Epub 2015 Nov 4.
PubMed 26537445
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the BioFire FilmArray® BioThreat-E Test for the Diagnosis of Ebola Virus Disease in West Africa
- ClinicalTrials.gov ID
- NCT02658331
- Acronym / sponsor ID
- EbolaFire
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola Virus Disease, Rapid Diagnosis, Point of care, Molecular platform
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Collaborators
- Fondation Mérieux, Donka University Hospital, Conakry
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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.
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.
Detailed description
The study will be conducted at the "Laboratoire des Fièvres Hémorragiques Virales" in Donka National Hospital (Conakry, Guinea), which is the Reference Laboratory for Hemorrhagic Fevers in Guinea. The reference based population includes the regions of Conakry and Coyah. No specific invasive intervention is required for this research protocol and the study does not interfere with the management of the patients according to the ongoing practices in Donka Ebola Treatment Center and in Coyah Ebola Treatment Center. Each participant will be verbally informed before signing an informed consent. Clinical data will be collected and recorded via a source document questionnaire - Clinical Report Form - based on the routine clinical data already provided to the laboratory according to the practices. Another questionnaire will be submitted to the biologist and technicians involved in the study to assess the practicability of the FilmArray technology, compared to conventional techniques, in terms of time to results, duration of test manipulation, sense of personnel safety for specimen handling, overall workload after each day, and preference of lab professionals.
As the main objective, analytical performance (sensitivity and specificity) and clinical performance (positive and negative predictive values) of the FA BioThreat-E test in whole blood will be evaluated in comparison with the QuantiTect® Probe RT-PCR (Qiagen) and the RealStar® Filovirus Type RT-PCR Kit 1.0 (Altona) both tests performed on serum.
The status for EVD will be defined for each patient based on the result of routine testing:
- Positive patients: patients enrolled in the study showing positive results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Negative patients: patients enrolled in the study showing negative results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Equivocal patients: all other results showing a discrepancy between the two routine tests.
As a secondary objective, the possibility of using the FilmArray (FA) BioThreat-E test on non-invasive specimens will also be assessed. Urine and saliva specimens will be analyzed by FA for confirmed positive cases only (based on routine testing), for patients able to provide saliva and/or urine specimens according to their health condition.
This research protocol was approved by the Guinean Ethical Committee.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of Ebola Virus Disease according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
Key inclusion criteria (2 listed)
- All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of EVD according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
- Ability to deliver a written informed consent
Key exclusion criteria (3 listed)
- Age below 18.
- Inability to provide a consent
- Inability to provide the blood specimens required for Ebola virus disease diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood.
Time frame: Through study completion, an average of 6 months.
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test in comparision with their Ebola Virus Disease status as defined based on the result of routine testing.
2 secondary outcomes
Number of urine specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a urine specimen.
Time frame: Through study completion, an average of 6 months.
Number of saliva specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a saliva specimen.
Time frame: Through study completion, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Background: PubMed 25972415Leski TA, Ansumana R, Taitt CR, Lamin JM, Bangura U, Lahai J, Mbayo G, Kanneh MB, Bawo B, Bockarie AS, Scullion M, Phillips CL, Horner CP, Jacobsen KH, Stenger DA. Use of the FilmArray System for Detection of Zaire ebolavirus in a Small Hospital in Bo, Sierra Leone. J Clin Microbiol. 2015 Jul;53(7):2368-70. doi: 10.1128/JCM.00527-15. Epub 2015 May 13.
- Background: PubMed 26157148Southern TR, Racsa LD, Albarino CG, Fey PD, Hinrichs SH, Murphy CN, Herrera VL, Sambol AR, Hill CE, Ryan EL, Kraft CS, Campbell S, Sealy TK, Schuh A, Ritchie JC, Lyon GM 3rd, Mehta AK, Varkey JB, Ribner BS, Brantly KP, Stroher U, Iwen PC, Burd EM. Comparison of FilmArray and Quantitative Real-Time Reverse Transcriptase PCR for Detection of Zaire Ebolavirus from Contrived and Clinical Specimens. J Clin Microbiol. 2015 Sep;53(9):2956-60. doi: 10.1128/JCM.01317-15. Epub 2015 Jul 8.
- Background: PubMed 26537445Weller SA, Bailey D, Matthews S, Lumley S, Sweed A, Ready D, Eltringham G, Richards J, Vipond R, Lukaszewski R, Payne PM, Aarons E, Simpson AJ, Hutley EJ, Brooks T. Evaluation of the Biofire FilmArray BioThreat-E Test (v2.5) for Rapid Identification of Ebola Virus Disease in Heat-Treated Blood Samples Obtained in Sierra Leone and the United Kingdom. J Clin Microbiol. 2016 Jan;54(1):114-9. doi: 10.1128/JCM.02287-15. Epub 2015 Nov 4.
- Individual participant dataSharing planned: No
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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.
Françoise Gay-Andrieu, MD-PhD study chair
BioMérieux
N'Fally Magassouba, PhD principal investigator
Laboratoire des Fièvres Hémorragiques en Guinée - Université Gamal Nasser, Conakry.
Mark Miller, MD-FRCPC study director
BioMérieux
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Virus Disease, run by BioMérieux.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood. (time frame: Through study completion, an average of 6 months.). 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 NCT02658331, which also lists 3 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 18 Jan 2016.