GonorrheaNCT02099760
Cepheid Rectal Sample Validation Study
An observational study of Gonorrhea and Chlamydia, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea, Chlamydia, Trichomonas
- What is being tested?
- STD testing (GC/Ct/trich)
- Type of treatment
- Medical device
- How many people
- 402 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects presenting for routine clinical care in an STD Clinic and/or subjects who are aware of the study and meet the inclusion/exclusion criteria.
Who may be able to join
- Male and female participants aged 18 and older
- Women or men who have a history of engaging in receptive anal intercourse
- Willing to provide written informed consent for participation in this study
Who cannot join
- Use of oral antibiotics in the past 7 days
- Use of rectal douche or other rectal product in the past 24 hours
- If female, use of a vaginal douche or vaginal product in the past 24 hours
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Allegheny County Health Department Sexually Transmitted Diseases Clinic
Pittsburgh, Pennsylvania, 15213
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Validation Study of the Cepheid Xpert CT/NG for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples
The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.
A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen.
The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Read the detailed description
Because of its high sensitivity and specificity, NAAT testing has largely replaced bacterial culture for the diagnosis of genital CT and GC in both males and females. NAAT assays have the greatest potential for detecting CT and GC in the rectum; however, no NAAT is currently cleared for use with extragenital specimens by the US Food and Drug Administration.
In order to comply with CLIA regulations, laboratories must perform in-house validations to use NAATs with rectal and pharyngeal specimens. There are multiple studies in the literature evaluating NAAT assays in diagnosing CT and GC in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory NAAT assays. The proposed validation study is intended to provide data to support the use of NAAT for rectal and pharyngeal specimens.
- Conditions
- Gonorrhea, Chlamydia, Trichomonas
- Being tested
- STD testing (GC/Ct/trich)
- Keywords
- gonorrhea, chlamydia, trichomonas
- Medical subject headings
- Gonorrhea, Chlamydia Infections, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STD testing (GC/Ct/trich)Device
Also called Cepheid Xpert CT/NG
| Study group | Role | What they receive |
|---|---|---|
| STD testing (GC/Ct/trich) | Not described Receives: Device: STD testing (GC/Ct/trich) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal Gonorrhea/Chlamydia testing result
Compare the sensitivity and specificity of the Xpert NG to the AC2 and culture in detecting GC in rectal samples Compare the sensitivity and specificity of the Xpert CT to AC2 (and as necessary, for discrepant results, to Aptima CT assay) in detecting CT in rectal samples
Measured: approximately 7 days
Secondary outcomes (2)
pharyngeal GC/Ct result
The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.
Measured: approximately 7 days
Trichomonas Testing Results
evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2
Measured: approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Hillier, University of Pittsburgh
- Investigators
- Sharon Hillier, PhD, Principal investigator, University of Pittsburgh/UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099760
- Sponsor's protocol ID
- PRO13100170
- Other IDs
- 5U01AI068633-04
- Status last verified
- Feb 2019
- First submitted
- 12 Mar 2014
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of the Cepheid Xpert CT/NG for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples
- ClinicalTrials.gov ID
- NCT02099760
- Acronym / sponsor ID
- PRO13100170
- Conditions
- Gonorrhea, Chlamydia, Trichomonas
- Keywords
- gonorrhea, chlamydia, trichomonas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Mar 2014 (estimated)
- 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.
The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.
A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen.
The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Detailed description
Because of its high sensitivity and specificity, NAAT testing has largely replaced bacterial culture for the diagnosis of genital CT and GC in both males and females. NAAT assays have the greatest potential for detecting CT and GC in the rectum; however, no NAAT is currently cleared for use with extragenital specimens by the US Food and Drug Administration.
In order to comply with CLIA regulations, laboratories must perform in-house validations to use NAATs with rectal and pharyngeal specimens. There are multiple studies in the literature evaluating NAAT assays in diagnosing CT and GC in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory NAAT assays. The proposed validation study is intended to provide data to support the use of NAAT for rectal and pharyngeal specimens.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STD testing (GC/Ct/trich) | – | Device: STD testing (GC/Ct/trich) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting for routine clinical care in an STD Clinic and/or subjects who are aware of the study and meet the inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- Male and female participants aged 18 and older
- Women or men who have a history of engaging in receptive anal intercourse
- Willing to provide written informed consent for participation in this study
Key exclusion criteria (3 listed)
- Use of oral antibiotics in the past 7 days
- Use of rectal douche or other rectal product in the past 24 hours
- If female, use of a vaginal douche or vaginal product in the past 24 hours
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 |
|---|---|---|
| STD testing (GC/Ct/trich)Also: Cepheid Xpert CT/NG | Device | STD testing (GC/Ct/trich) |
Primary outcome
Rectal Gonorrhea/Chlamydia testing result
Time frame: approximately 7 days
Compare the sensitivity and specificity of the Xpert NG to the AC2 and culture in detecting GC in rectal samples Compare the sensitivity and specificity of the Xpert CT to AC2 (and as necessary, for discrepant results, to Aptima CT assay) in detecting CT in rectal samples
2 secondary outcomes
pharyngeal GC/Ct result
Time frame: approximately 7 days
Trichomonas Testing Results
Time frame: approximately 7 days
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 7 Feb 2019.
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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.
Sharon Hillier, PhD principal investigator
University of Pittsburgh/UPMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonorrhea and Chlamydia, run by University of Pittsburgh at 2 sites 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: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rectal Gonorrhea/Chlamydia testing result (time frame: approximately 7 days). 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 7 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.