Xpert® Tropical Fever Test on GeneXpert® Edge X System

N/AEnrolling By InvitationNCT07520279

Cepheid2,500 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Malaria Fever Zika Dengue Fever Leptospirosis Chikungunya Virus Infection

Interventions

Xpert Tropical Fever testDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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)

Locations (1)

Naval Health Research Center

San Diego, California, United States

Outcomes

Primary Outcomes

Clinical performance [PPA and NPA] of Xpert Tropical Fever

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

Time frame: Clinical performance on specimens collected at Baseline (Day 0)

Data from ClinicalTrials.gov

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