Xpert® Tropical Fever Test on GeneXpert® Edge X System (NCT07520279) | Clinical Trial Compass
By InvitationNot Applicable
Xpert® Tropical Fever Test on GeneXpert® Edge X System
United States2,500 participantsStarted 2025-08-18
Plain-language summary
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
Who can participate
Age range14 Years
SexALL
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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)
What they're measuring
1
Clinical performance [PPA and NPA] of Xpert Tropical Fever
Timeframe: Clinical performance on specimens collected at Baseline (Day 0)