Xpert® Tropical Fever Test on GeneXpert® Edge X System

April 7, 2026 updated by: Cepheid

Clinical Evaluation of the Xpert® Tropical Fever Test on the GeneXpert® Edge System Using Venous and Capillary Whole Blood Specimens

This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Capillary and venous whole blood specimens will be prospectively collected from consented individuals who present with acute febrile illness and clinical suspicion of infection with fever-causing agents

Study Type

Observational

Enrollment (Estimated)

2500

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

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Health Research Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Whole blood specimens collected from individuals with AFI and infection caused by fever-causing pathogens

Description

Inclusion Criteria:

  • Presents with AFI as defined for endemic populations or fever as defined in non-endemic populations or presents with fever as defined for nonendemic populations
  • Clinical suspicion of disease caused by at least one of the following: Plasmodium spp, dengue virus, Zika virus, chikungunya virus, or Leptospira (endemic population)
  • History of residence in or travel to an endemic geographic region within 3 months prior to specimen collection (endemic population)

Exclusion Criteria:

  • Self-reported or known antibiotic or antimalarial use (oral or intravenous) within 3 days prior to enrollment (endemic and nonendemic population)
  • History of residence in or trael to endemic geographic region as defined by protocol ≤ three months prior to specimen collection (nonendemic population)
  • Clinical suspicion of infection caused by any of the following: Plasmodium spp., dengue virus, Zika virus, chikungunya virus, or Leptospira spp. (nonendemic population)

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
Capillary and venous WB specimens
WB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent
Diagnostic test: Xpert Tropical Fever test
Detection and identification of nucleic acids from multiple fever-causing pathogens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance [PPA and NPA] of Xpert Tropical Fever
Time Frame: Clinical performance on specimens collected at Baseline (Day 0)
Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)
Clinical performance on specimens collected at Baseline (Day 0)

Collaborators and Investigators

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

Sponsor

Cepheid

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)

August 18, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P258C2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Dengue Fever

Clinical Trials on Xpert Tropical Fever test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe