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 range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical performance [PPA and NPA] of Xpert Tropical Fever
Timeframe: Clinical performance on specimens collected at Baseline (Day 0)