Xpert® Tropical Fever Test on GeneXpert® Edge X System

NCT07520279 | Enrolling By Invitation FDA Device

• 1 other identifier: P258C2
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Zika; Malaria Fever; Dengue Fever; Leptospirosis; Chikungunya Virus Infection

Outcome Measures

Primary Outcomes (1)

• Clinical performance [PPA and NPA] of Xpert Tropical Fever

  Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)

  Clinical performance on specimens collected at Baseline (Day 0)

Study Arms (1)

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

Interventions

Xpert Tropical Fever test DIAGNOSTIC_TEST

Detection and identification of nucleic acids from multiple fever-causing pathogens.

Capillary and venous WB specimens

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cepheid: lead

Study Sites (1)

Naval Health Research Center

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Malaria; Zika Virus Infection; Dengue; Leptospirosis; Chikungunya Fever

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Alphavirus Infections; Togaviridae Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 9, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)