Clinical Evaluation of the FilmArray® Global Fever (GF) Panel

Completed

• Conditions: Fever
• Interventions: Other: Observational study

• Registration Number: NCT02968355
• Lead Sponsor: BioFire Defense LLC

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.

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Study Start: 2018-03-26
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2084

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects/Specimens	Observational study	Subjects/Specimens that meet the eligibility criteria

Primary Outcome Measures

Name	Time	Method
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel	18 months	Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay

Trial Locations

Locations (11)

Naval Medical Research Unit Two; 🇰🇭 Phnom Penh, Cambodia

Naval Medical Research Unit Six; 🇵🇪 Iquitos, Peru

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania

United States Army Medical Research Directorate Georgia; 🇬🇪 Tbilisi, Georgia

Universidad Nacional Autonoma de Honduras; 🇭🇳 Tegucigalpa, Central District, Honduras

United States Army Medical Research Directorate Kenya; 🇰🇪 Kisumu, Kenya

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda

Naval Medical Research Unit Three; 🇬🇭 Navrongo, Ghana

Armed Forces Research Institute of Medical Sciences; 🇹🇭 Bangkok, Thailand

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States