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Xpert® Tropical Fever Test on GeneXpert® Edge X System

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602572282015
Enrollment
2500
Registered
2026-02-06
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Malaria Dengue fever, chikungunya fever, Zika virus disease, Leptospirosis

Interventions

Sponsors

Cepheid
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals 14 years and older who: - presents with AFI as defined for endemic populations or presents with fever for non-endemic populations - has clinical suspicion of disease caused by at least one of the following: Plasmodium spp, dengue virus, Zika virus, chikunguyna virus, or Leptospira (endemic population) - had a history of residence in or travel to an endemic geographic region within 3 months prior to specimen collection (endemic population)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Clinical Performance, PPA and NPA, of Xpert Tropical Fever test relative to comparators for the fever-causing agents

Secondary

MeasureTime frame
Assessing the non-determinate rate of the Xpert Tropical Fever Test in whole blood specimens

Countries

Ghana

Contacts

Public ContactSarah Brown

Cepheid Senior Director Clinical Programs

sarah.brown@cepheid.com+18472710502

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026