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Completed

NCT Number: NCT02968355

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

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

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Research Unit Two, Phnom Penh, Cambodia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational study

Other

Observational study

Other names: FilmArray

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

BioFire Defense LLC

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • United States Department of Defense

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2016
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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