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

NCT ID: NCT02968355

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2084 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-26

Study Completion Date

2021-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Fever

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects/Specimens

Subjects/Specimens that meet the eligibility criteria

Observational study

Intervention Type OTHER

Observational study

Interventions

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Observational study

Observational study

Intervention Type OTHER

Other Intervention Names

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FilmArray

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

BioFire Defense LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia Phillips, Ph. D.

Role: STUDY_DIRECTOR

BioFire Defense LLC

Locations

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George Washington University

Washington D.C., District of Columbia, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Naval Medical Research Unit Two

Phnom Penh, , Cambodia

Site Status

United States Army Medical Research Directorate Georgia

Tbilisi, , Georgia

Site Status

Naval Medical Research Unit Three

Navrongo, , Ghana

Site Status

Universidad Nacional Autonoma de Honduras

Tegucigalpa, Central District, Honduras

Site Status

United States Army Medical Research Directorate Kenya

Kisumu, , Kenya

Site Status

Naval Medical Research Unit Six

Iquitos, , Peru

Site Status

Kilimanjaro Christian Medical Centre

Moshi, , Tanzania

Site Status

Armed Forces Research Institute of Medical Sciences

Bangkok, , Thailand

Site Status

Infectious Diseases Institute

Kampala, , Uganda

Site Status

Countries

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United States Cambodia Georgia Ghana Honduras Kenya Peru Tanzania Thailand Uganda

References

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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.

Reference Type DERIVED
PMID: 35716700 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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HHSN272201600002C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W911QY-13-D-0080

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SDY-017266

Identifier Type: -

Identifier Source: org_study_id

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