NCT02968355

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,084

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
10 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

November 16, 2016

Last Update Submit

July 2, 2024

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Subjects/Specimens

Subjects/Specimens that meet the eligibility criteria

Other: Observational study

Interventions

Observational studyOTHER

Observational study

Also known as: FilmArray
Subjects/Specimens

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Naval Medical Research Unit Two

Phnom Penh, Cambodia

Location

United States Army Medical Research Directorate Georgia

Tbilisi, Georgia

Location

Naval Medical Research Unit Three

Navrongo, Ghana

Location

Universidad Nacional Autonoma de Honduras

Tegucigalpa, Central District, Honduras

Location

United States Army Medical Research Directorate Kenya

Kisumu, Kenya

Location

Naval Medical Research Unit Six

Iquitos, Peru

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Armed Forces Research Institute of Medical Sciences

Bangkok, Thailand

Location

Infectious Diseases Institute

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 35716700DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimen may be retained at the participating clinical sites for future use. Specimen nucleic acid may be retained at BioFire and participating clinical sites for future performance evaluations of the FilmArray.

MeSH Terms

Conditions

Fever

Interventions

Observation

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Cynthia Phillips, Ph. D.

    BioFire Defense LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

March 26, 2018

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.

Locations

TH(1)US(2)GH(1)UG(1)GE(1)KE(1)TA(1)HO(1)CA(1)PE(1)