Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02968355
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
United States Department of Defense
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
BioFire Defense LLC

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

Condition or disease Intervention/treatment
Fever Other: Observational study

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Evaluation of the FilmArray® Global Fever (GF) Panel
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
Subjects/Specimens
Subjects/Specimens that meet the eligibility criteria
Other: Observational study
Observational study
Other Name: FilmArray




Primary Outcome Measures :
  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


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with fever will be prospectively enrolled, and whole blood will be collected.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968355


Contacts
Layout table for location contacts
Contact: Cynthia Andjelic, Ph. D. 801-262-3592 ext 1173 Cynthia.Andjelic@BioFireDefense.com

Locations
Layout table for location information
United States, District of Columbia
George Washington University Not yet recruiting
Washington, District of Columbia, United States, 20037
Contact: Aileen Chang, MD         
Principal Investigator: Chris Mores, PhD         
United States, Missouri
Washington University Active, not recruiting
Saint Louis, Missouri, United States, 63110
Cambodia
Naval Medical Research Unit Two Recruiting
Phnom Penh, Cambodia
Contact: Kimberly Edgel, PhD         
Georgia
United States Army Medical Research Directorate Georgia Not yet recruiting
Tbilisi, Georgia
Contact: Tamar Akhvlediani, MD, PhD         
Ghana
Naval Medical Research Unit Three Not yet recruiting
Navrongo, Ghana
Contact: Andrew Letizia, MD         
Principal Investigator: Abraham Oduro, PhD         
Sub-Investigator: Anne Fox, MD         
Sub-Investigator: Michael Kaburise, MD         
Sub-Investigator: Lucas Amenga, PhD         
Sub-Investigator: Victor Asoala, PhD         
Honduras
Universidad Nacional Autonoma de Honduras Not yet recruiting
Tegucigalpa, Central District, Honduras
Contact: Ivette Lorenzana, MS         
Kenya
United States Army Medical Research Directorate Kenya Not yet recruiting
Kisumu, Kenya
Contact: John Waitumbi, DVM, PhD         
Peru
Naval Medical Research Unit Six Recruiting
Iquitos, Peru
Contact: Crystyan Siles, MD         
Tanzania
Kilimanjaro Christian Medical Centre Recruiting
Moshi, Tanzania
Contact: Venance Maro, MD         
Principal Investigator: Venance Maro, MD         
Sub-Investigator: Matthew Rubach, MD         
Thailand
Armed Forces Research Institute of Medical Sciences Recruiting
Bangkok, Thailand
Contact: Stefan Fernandez, PhD         
Uganda
Infectious Diseases Institute Recruiting
Kampala, Uganda
Contact: Yukari Manabe, MD         
Principal Investigator: Mohammed Lamorde, PhD         
Sponsors and Collaborators
BioFire Defense LLC
United States Department of Defense
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Study Director: Cynthia Phillips, Ph. D. BioFire Defense LLC

Layout table for additonal information
Responsible Party: BioFire Defense LLC
ClinicalTrials.gov Identifier: NCT02968355     History of Changes
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 )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

Additional relevant MeSH terms:
Layout table for MeSH terms
Fever
Body Temperature Changes
Signs and Symptoms