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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 29 November 2021
Main ID:  NCT02968355
Date of registration: 16/11/2016
Prospective Registration: Yes
Primary sponsor: BioFire Defense LLC
Public title: Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
Scientific title: Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
Date of first enrolment: March 26, 2018
Target sample size: 2084
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02968355
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Cambodia Georgia Ghana Honduras India Kenya Peru Tanzania
Thailand Uganda United States
Contacts
Name:     Cynthia Phillips, Ph. D.
Address: 
Telephone:
Email:
Affiliation:  BioFire Defense LLC
Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Fever
Intervention(s)
Other: Observational study
Primary Outcome(s)
Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel [Time Frame: 18 months]
Secondary Outcome(s)
Secondary ID(s)
HHSN272201600002C
SDY-017266
W911QY-13-D-0080
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
United States Department of Defense
National Institute of Allergy and Infectious Diseases (NIAID)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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