FeverNCT02968355
Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
An observational study of Fever, run by BioFire Defense LLC at 11 sites in 10 countries.
Trial summary
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fever
- What is being tested?
- Observational study
- How many people
- 2,084 participants
- Where
- 11 sitesin 10 countries
- Study dates
- 26 Mar 2018to 30 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with fever will be prospectively enrolled, and whole blood will be collected.
Who may be able to join
- Whole blood in EDTA (prospectively collected via informed consent)
- Subject has a recorded or self-reported fever within the past two days.
- Subject has not participated in the study within the last 30 days.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 10 countries.
11 sites in 10 countries
United States2 sites
Washington University
St Louis, Missouri, 63110
George Washington University
Washington D.C., District of Columbia, 20037
Honduras1 site
Universidad Nacional Autonoma de Honduras
Tegucigalpa, Central District
About this study
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.
Read the detailed description
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.
- Conditions
- Fever
- Being tested
- Observational study
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Also called FilmArray
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Subjects/Specimens | Subjects/Specimens that meet the eligibility criteria Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start26 Mar 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- Prospective
- Enrolment
- 2,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFire Defense LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Cynthia Phillips, Ph. D., Study director, BioFire Defense LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968355
- Sponsor's protocol ID
- SDY-017266
- Other IDs
- HHSN272201600002C, W911QY-13-D-0080
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2016
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Manabe YC, Betz J, Jackson O, Asoala V, Bazan I, Blair PW, Chang A, Chusri S, Crump JA, Edgel KA, Faix DJ, Fernandez S, Fox AT, Garcia JA, Grogl M, Hansen EA, Heang V, House SL, Jongsakul K, Kaburise MB, Klungthong C, Lamorde M, Letizia AG, Lorenzana I, Luy M, Maro VP, Mores CN, Myers CA, Oduro AR, Parham L, Porzucek AJ, Prouty M, Rabiger DS, Rubach MP, Siles C, Silva M, Ukachu C, Waitumbi JN, Phillips CL, Jones BW. Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study. Lancet Infect Dis. 2022 Sep;22(9):1356-1364. doi: 10.1016/S1473-3099(22)00290-0. Epub 2022 Jun 15.
PubMed 35716700
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
- ClinicalTrials.gov ID
- NCT02968355
- Acronym / sponsor ID
- SDY-017266
- Conditions
- Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,084 participants (actual)
- Lead sponsor
- BioFire Defense LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 18 Nov 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.
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.
Detailed description
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P. ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the sensitivity and specificity of the GF Panel when used to test blood collected from subjects with fever or who have recently had fever. This multi-center study is being conducted at locations around the world.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects/Specimens | – | Other: Observational studySubjects/Specimens that meet the eligibility criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with fever will be prospectively enrolled, and whole blood will be collected.
Key inclusion criteria (3 listed)
- Whole blood in EDTA (prospectively collected via informed consent)
- Subject has a recorded or self-reported fever within the past two days.
- Subject has not participated in the study within the last 30 days.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Observational studyAlso: FilmArrayObservational study | Other | Subjects/Specimens |
Primary outcome
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
Time frame: 18 months
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
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 5 Jul 2024.
- Derived from this study: PubMed 35716700Manabe YC, Betz J, Jackson O, Asoala V, Bazan I, Blair PW, Chang A, Chusri S, Crump JA, Edgel KA, Faix DJ, Fernandez S, Fox AT, Garcia JA, Grogl M, Hansen EA, Heang V, House SL, Jongsakul K, Kaburise MB, Klungthong C, Lamorde M, Letizia AG, Lorenzana I, Luy M, Maro VP, Mores CN, Myers CA, Oduro AR, Parham L, Porzucek AJ, Prouty M, Rabiger DS, Rubach MP, Siles C, Silva M, Ukachu C, Waitumbi JN, Phillips CL, Jones BW. Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study. Lancet Infect Dis. 2022 Sep;22(9):1356-1364. doi: 10.1016/S1473-3099(22)00290-0. Epub 2022 Jun 15.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
Related trials for Fever
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 2
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
Lassa Fever
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
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.
Cynthia Phillips, Ph. D. study director
BioFire Defense LLC
11 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by BioFire Defense LLC at 11 sites in 10 countries.
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 3 inclusion and 0 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Cambodia, Georgia, Ghana, Honduras and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel (time frame: 18 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 NCT02968355, which also lists 1 linked publication.
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 5 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.