ClinicalTrials.gg
Sign In
Enrolling by invitationNCT07520279Updated Apr 9, 2026

Xpert® Tropical Fever Test on GeneXpert® Edge X System

An observational study in Malaria Fever, Zika and Dengue Fever, sponsored by Cepheid. Enrolling by invitation at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Cepheid (part of Danaher Corporation) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
14 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Malaria Fever
  • Zika
  • Dengue Fever
  • Leptospirosis
  • Chikungunya Virus Infection
03

In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 582 across 204 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

First submitted after Cepheid became part of Danaher Corporation.

Browse Cepheid studies →All Danaher Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Whole blood specimens collected from individuals with AFI and infection caused by fever-causing pathogens

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Capillary and venous WB specimens

    WB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent

    Diagnostic Test: Xpert Tropical Fever test

Interventions

  • Diagnostic testXpert Tropical Fever test

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

06

What researchers measure

Primary outcomes

  1. 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)

07

Study locations

1 site
  • Naval Health Research Center
    San Diego, California 92134, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.

Of 93 observational studies under Malaria, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Apr 9, 2026
StartActual
Aug 18, 2025
Primary completionEst.
Aug 31, 2026
CompletionEst.
Feb 28, 2027
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07520279
Lead sponsor
Cepheid
Responsible party
Sponsor
First posted
Apr 9, 2026
Start date
Aug 18, 2025
Primary completion
Aug 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Apr 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Malaria →

Other studies from this sponsor

Cepheid →

Start the discussion