Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
NCT ID: NCT02968355
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2084 participants
OBSERVATIONAL
2018-03-26
2021-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Subjects/Specimens
Subjects/Specimens that meet the eligibility criteria
Observational study
Observational study
Interventions
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Observational study
Observational study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
ALL
No
Sponsors
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United States Department of Defense
FED
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
BioFire Defense LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Phillips, Ph. D.
Role: STUDY_DIRECTOR
BioFire Defense LLC
Locations
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George Washington University
Washington D.C., District of Columbia, United States
Washington University
St Louis, Missouri, United States
Naval Medical Research Unit Two
Phnom Penh, , Cambodia
United States Army Medical Research Directorate Georgia
Tbilisi, , Georgia
Naval Medical Research Unit Three
Navrongo, , Ghana
Universidad Nacional Autonoma de Honduras
Tegucigalpa, Central District, Honduras
United States Army Medical Research Directorate Kenya
Kisumu, , Kenya
Naval Medical Research Unit Six
Iquitos, , Peru
Kilimanjaro Christian Medical Centre
Moshi, , Tanzania
Armed Forces Research Institute of Medical Sciences
Bangkok, , Thailand
Infectious Diseases Institute
Kampala, , Uganda
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HHSN272201600002C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
W911QY-13-D-0080
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SDY-017266
Identifier Type: -
Identifier Source: org_study_id
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