Xpert® Tropical Fever Test on GeneXpert® Edge X System

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07520279

Enrollment

2500

Registered

2026-04-09

Start date

2025-08-18

Completion date

2027-02-28

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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

Interventions

DIAGNOSTIC_TESTXpert Tropical Fever test

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026