Clinical trial NCT02968355: Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
Official title: Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: BioFire Defense LLC
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-11-18
Enrollment: 2084
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with fever will be prospectively enrolled, and whole blood will be collected.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Phnom Penh
country: Cambodia
facility: Naval Medical Research Unit Two
city: Tbilisi
country: Georgia
facility: United States Army Medical Research Directorate Georgia
city: Navrongo
country: Ghana
facility: Naval Medical Research Unit Three
city: Tegucigalpa
country: Honduras
facility: Universidad Nacional Autonoma de Honduras
state: Central District
city: Kisumu
country: Kenya
facility: United States Army Medical Research Directorate Kenya
city: Iquitos
country: Peru
facility: Naval Medical Research Unit Six
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
city: Bangkok
country: Thailand
facility: Armed Forces Research Institute of Medical Sciences
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
Study officials:
affiliation: BioFire Defense LLC
name: Cynthia Phillips, Ph. D.
role: STUDY_DIRECTOR
References:
citation: 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.