Malaria FeverNCT07520279
Xpert® Tropical Fever Test on GeneXpert® Edge X System
An observational study of Malaria Fever and Zika, run by Cepheid at 1 site in United States.
Trial summary
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Malaria Fever, Zika, Dengue Fever
- What is being tested?
- Xpert Tropical Fever test
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Whole blood specimens collected from individuals with AFI and infection caused by fever-causing pathogens
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Health Research Center
San Diego, California, 92134
About this study
Official title: Clinical Evaluation of the Xpert® Tropical Fever Test on the GeneXpert® Edge System Using Venous and Capillary Whole Blood Specimens
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
- Conditions
- Malaria Fever, Zika, Dengue Fever, Leptospirosis, Chikungunya Virus Infection
- Being tested
- Xpert Tropical Fever test
- Medical subject headings
- Malaria, Zika Virus Infection, Dengue, Leptospirosis, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert Tropical Fever testDiagnostic test
Detection and identification of nucleic acids from multiple fever-causing pathogens.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Xpert Tropical Fever test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance [PPA and NPA] of Xpert Tropical Fever
Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)
Measured: Clinical performance on specimens collected at Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start18 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520279
- Sponsor's protocol ID
- P258C2
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert® Tropical Fever Test on the GeneXpert® Edge System Using Venous and Capillary Whole Blood Specimens
- ClinicalTrials.gov ID
- NCT07520279
- Acronym / sponsor ID
- P258C2
- Conditions
- Malaria Fever, Zika, Dengue Fever, Leptospirosis, Chikungunya Virus Infection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary and venous WB specimens | – | Diagnostic Test: Xpert Tropical Fever testWB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Whole blood specimens collected from individuals with AFI and infection caused by fever-causing pathogens
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert Tropical Fever testDetection and identification of nucleic acids from multiple fever-causing pathogens. | Diagnostic test | Capillary and venous WB specimens |
Primary outcome
Clinical performance [PPA and NPA] of Xpert Tropical Fever
Time frame: Clinical performance on specimens collected at Baseline (Day 0)
Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria Fever and Zika, run by Cepheid at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance [PPA and NPA] of Xpert Tropical Fever (time frame: Clinical performance on specimens collected at Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.