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NCT02968355 Clinical Trial

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

Fever Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02968355
Other study ID # SDY-017266
Secondary ID HHSN272201600002
Status Active, not recruiting
Phase
First received
Last updated
Start date March 26, 2018
Est. completion date June 2022

Study information
Verified date November 2021
Source BioFire Defense LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2084
Est. completion date June 2022
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational study
Observational study

Locations
Country Name City State
Cambodia Naval Medical Research Unit Two Phnom Penh
Georgia United States Army Medical Research Directorate Georgia Tbilisi
Ghana Naval Medical Research Unit Three Navrongo
Honduras Universidad Nacional Autonoma de Honduras Tegucigalpa Central District
Kenya United States Army Medical Research Directorate Kenya Kisumu
Peru Naval Medical Research Unit Six Iquitos
Tanzania Kilimanjaro Christian Medical Centre Moshi
Thailand Armed Forces Research Institute of Medical Sciences Bangkok
Uganda Infectious Diseases Institute Kampala
United States Washington University Saint Louis Missouri
United States George Washington University Washington District of Columbia

Sponsors (3)
Lead Sponsor Collaborator
BioFire Defense LLC National Institute of Allergy and Infectious Diseases (NIAID), United States Department of Defense

Countries where clinical trial is conducted

United States,  Cambodia,  Georgia,  Ghana,  Honduras,  Kenya,  Peru,  Tanzania,  Thailand,  Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay 18 months
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