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Enrolling by invitation NCT07520279

Xpert® Tropical Fever Test on GeneXpert® Edge X System

— Observational Malaria Fever Zika Dengue Fever Leptospirosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xpert Tropical Fever test.
Who it may be relevant to
Registry conditions: Malaria Fever, Zika, Dengue Fever, Leptospirosis. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test Xpert Tropical Fever test
    Detection and identification of nucleic acids from multiple fever-causing pathogens.

Primary outcome measures

  • Clinical performance [PPA and NPA] of Xpert Tropical Fever [Time frame: Clinical performance on specimens collected at Baseline (Day 0)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Naval Health Research Center — San Diego

Identifiers

NCT: NCT07520279 · P258C2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗