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

November 16, 2021 updated by: BioFire Defense LLC
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2084

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cambodia
      • Phnom Penh, Cambodia
        • Naval Medical Research Unit Two
  • Georgia
      • Tbilisi, Georgia
        • United States Army Medical Research Directorate Georgia
  • Ghana
      • Navrongo, Ghana
        • Naval Medical Research Unit Three
  • Honduras
    • Central District
      • Tegucigalpa, Central District, Honduras
        • Universidad Nacional Autonoma de Honduras
  • Kenya
      • Kisumu, Kenya
        • United States Army Medical Research Directorate Kenya
  • Peru
      • Iquitos, Peru
        • Naval Medical Research Unit Six
  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre
  • Thailand
      • Bangkok, Thailand
        • Armed Forces Research Institute of Medical Sciences
  • Uganda
      • Kampala, Uganda
        • Infectious Diseases Institute
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with fever will be prospectively enrolled, and whole blood will be collected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects/Specimens
Subjects/Specimens that meet the eligibility criteria
Other: Observational study
Observational study
Other Names:
  • FilmArray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioFire Defense LLC

Collaborators

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

Investigators

  • Study Director: Cynthia Phillips, Ph. D., BioFire Defense LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2018

Primary Completion (Actual)

March 30, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDY-017266
  • HHSN272201600002C (Other Grant/Funding Number: NIAID)
  • W911QY-13-D-0080 (Other Grant/Funding Number: U.S. Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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