Respiratory Tract InfectionsNCT07489846
Xpert® ERP on the GeneXpert® System
An observational study of Respiratory Tract Infections, run by Cepheid at 1 site in United States.
Trial summary
A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Xpert ERP
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 2 Feb 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specimens collected from individuals with signs and symptoms of respiratory tract infection
Who may be able to join
- NPS specimen from participant who presents with signs and symptoms of RTI
- NPS specimen collected in commercially available UTM/VTM only
Who cannot join
- NPS specimen collected from a participant previously enrolled in this study
- Principal Investigator feels the participant is not suitable to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Xpert® Expanded Respiratory Panel on the GeneXpert® System Using Nasopharyngeal Swab Specimens
A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States
Read the detailed description
Prospectively collected Nasopharyngeal swab specimens will be collected from consented individuals with signs and symptoms of respiratory tract infection at a single timepoint
- Conditions
- Respiratory Tract Infections
- Being tested
- Xpert ERP
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert ERPDiagnostic test
Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal Swab Specimens | Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection Receives: Diagnostic Test: Xpert ERP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xpert test compared to comparator(s) tests
Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)
Measured: Clinical Performance assessed on 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 posted24 Mar 2026
- Study start13 May 2025
- Primary completion28 Jan 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489846
- Sponsor's protocol ID
- P286C
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert® Expanded Respiratory Panel on the GeneXpert® System Using Nasopharyngeal Swab Specimens
- ClinicalTrials.gov ID
- NCT07489846
- Acronym / sponsor ID
- P286C
- Conditions
- Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 24 Mar 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 observational all-comers study that will be conducted at geographically diverse sites within the United States
Detailed description
Prospectively collected Nasopharyngeal swab specimens will be collected from consented individuals with signs and symptoms of respiratory tract infection at a single timepoint
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal Swab Specimens | – | Diagnostic Test: Xpert ERPNasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens collected from individuals with signs and symptoms of respiratory tract infection
Key inclusion criteria (2 listed)
- NPS specimen from participant who presents with signs and symptoms of RTI
- NPS specimen collected in commercially available UTM/VTM only
Key exclusion criteria (2 listed)
- NPS specimen collected from a participant previously enrolled in this study
- Principal Investigator feels the participant is not suitable to participate in the study
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 ERPDetection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs | Diagnostic test | Nasopharyngeal Swab Specimens |
Primary outcome
Xpert test compared to comparator(s) tests
Time frame: Clinical Performance assessed on specimens collected at Baseline
Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s)
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 24 Mar 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 Respiratory Tract Infections, 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 2 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 24 Mar 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?
Xpert test compared to comparator(s) tests (time frame: Clinical Performance assessed on 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 24 Mar 2026.