Hemorrhagic FeverNCT07370454
Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System
An observational study of Hemorrhagic Fever, run by Cepheid at 1 site in United States.
Trial summary
A multi-site observation study that was conducted a geographically diverse sites across the United States Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Fever
- What is being tested?
- Xpert Hemorrhagic Fever test
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 3 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Whole blood specimens collected from blood donors symptomatic or asymptomatic of fever
Who may be able to join
- Capillary and venous whole blood specimens from blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
- Whole blood specimens collected in EDTA specimens collection devices only
Who cannot join
- Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
- Any whole blood specimen that were previously enrolled
- Any whole blood specimens not collected according to the manufacturer's instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Xpert Hemorrhagic Fever Test Using Clinical Specimens and Contrived Samples on the GeneXpert Edge X System
A multi-site observation study that was conducted a geographically diverse sites across the United States
Read the detailed description
Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever
- Conditions
- Hemorrhagic Fever
- Being tested
- Xpert Hemorrhagic Fever test
- Medical subject headings
- Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert Hemorrhagic Fever testDiagnostic test
Detection and identification of RNA from multiple viruses from whole blood specimens
| Study group | Role | What they receive |
|---|---|---|
| Capillary and venous whole blood specimens | whole blood specimens from individuals asymptomatic or symptomatic of fever Receives: Diagnostic Test: Xpert Hemorrhagic Fever test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens
Xpert test compared to expected status
Measured: Clinical Performance assessed in specimens collected at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start13 Jan 2025
- Primary completion29 Apr 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic 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
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370454
- Sponsor's protocol ID
- P259C
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2025
- Last updated
- 27 Jan 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert Hemorrhagic Fever Test Using Clinical Specimens and Contrived Samples on the GeneXpert Edge X System
- ClinicalTrials.gov ID
- NCT07370454
- Acronym / sponsor ID
- P259C
- Conditions
- Hemorrhagic Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 27 Jan 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.
A multi-site observation study that was conducted a geographically diverse sites across the United States
Detailed description
Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary and venous whole blood specimens | – | Diagnostic Test: Xpert Hemorrhagic Fever testwhole blood specimens from individuals asymptomatic or symptomatic of fever |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Whole blood specimens collected from blood donors symptomatic or asymptomatic of fever
Key inclusion criteria (2 listed)
- Capillary and venous whole blood specimens from blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
- Whole blood specimens collected in EDTA specimens collection devices only
Key exclusion criteria (3 listed)
- Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
- Any whole blood specimen that were previously enrolled
- Any whole blood specimens not collected according to the manufacturer's instructions
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 Hemorrhagic Fever testDetection and identification of RNA from multiple viruses from whole blood specimens | Diagnostic test | Capillary and venous whole blood specimens |
Primary outcome
Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens
Time frame: Clinical Performance assessed in specimens collected at Baseline
Xpert test compared to expected status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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. This study is not recruiting at the moment.
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 Hemorrhagic Fever, 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 2 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: finished, as of the sponsor's last update on 27 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 comparing Xpert Hemorrhagic Fever to known status of specimens (time frame: Clinical Performance assessed in specimens collected at Baseline). 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 27 Jan 2026.