Xpert® Tropical Fever Test on GeneXpert® Edge X System

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

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Key information

Conditions

Malaria Fever Alphavirus Infections Arbovirus Infections Bacterial Infections Bacterial Infections and Mycoses Chikungunya Fever Chikungunya Virus Infection Dengue Dengue Fever Flaviviridae Infections Flavivirus Infections Gram-Negative Bacterial Infections Hemorrhagic Fevers, Viral Infections Leptospirosis Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections RNA Virus Infections Spirochaetales Infections Togaviridae Infections Vector Borne Diseases Virus Diseases Zika Zika Virus Infection

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Health Research Center

San Diego, California, 92134, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Xpert Tropical Fever test

Diagnostic Test

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

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Apr 9, 2026
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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