GonorrheaNCT00827697
A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples
An observational study of Gonorrhea and Chlamydia, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2) will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Gen-Probe APTIMA Combo2 (AC2)
- How many people
- 399 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Mar 2010
- 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: Women (n=175) and men who have sex with men (n=224) with a lifetime history of anal intercourse by self-report
Who may be able to join
- Male and female subjects 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Pittsburgh AIDS Center for Treatment (PACT)
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples.
Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2) will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Read the detailed description
This research is being done to compare the results of tests for diagnosing sexually transmitted infections (STI) from rectal samples. Specifically, this study will test for gonorrhea and Chlamydia from rectal samples and compare the results between standard culture and newer technology (nucleic acid amplification testing otherwise know as "NAAT") used to detect these infections. Gonorrhea and Chlamydia are STIs (infections you get from having sex with someone who is infected). Infections in the rectum may cause symptoms such as rectal discharge, itching and/or pain or may be asymptomatic (no symptoms present). Since these infections are sexually transmitted, it is important to have accurate tests to diagnose and treat these infections to prevent them from being passed onto a sexual partner.
NAAT has not been Food and Drug Administration (FDA) approved for use in diagnosing these infections in the rectum. The tests are approved to detect these infections from other sites (cervix and urine) and investigators believe that these tests will be very accurate in detecting these infections in the rectum as well. This study will validate the use of NAAT in rectal samples so that this technology can be used in our research laboratory for future studies that involve testing for STIs from the rectum.
There are times when people have signs of inflammation in the rectum (known as proctitis) and an infection or cause is not able to be identified. Investigators believe that this new technology (NAAT) may be able to find reasons (different bacteria) for infection that were not able to be identified with older testing methods. By participating in this study, one of the rectal swabs will also be tested for additional bacteria (called Mycoplasma and Trichomonas). Both of these organisms are sexually transmitted and may be important organisms in the cause of proctitis.
- Being tested
- Gen-Probe APTIMA Combo2 (AC2)
- Keywords
- Gonorrhea, Chlamydia, Rectal
- Medical subject headings
- Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gen-Probe APTIMA Combo2 (AC2)Other
Laboratory Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of AC2 in detecting Neisseria gonorrhoeae in rectal samples
Sensitivity and specificity of AC2 to ProbeTec and culture in detecting Neisseria gonorrhoeae in rectal samples
Measured: Visit 1
Sensitivity and specificity of AC2 in detecting Chlamydia trachomatis in rectal samples
Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting Chlamydia trachomatis in rectal sample
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Sharon Hillier, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827697
- Sponsor's protocol ID
- PRO08120504
- Other IDs
- UM1AI068633, 5UM1AI106707
- Status last verified
- Aug 2016
- First submitted
- 21 Jan 2009
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples.
- ClinicalTrials.gov ID
- NCT00827697
- Acronym / sponsor ID
- PRO08120504
- Keywords
- Gonorrhea, Chlamydia, Rectal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Jan 2009 (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.
Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2) will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
Detailed description
This research is being done to compare the results of tests for diagnosing sexually transmitted infections (STI) from rectal samples. Specifically, this study will test for gonorrhea and Chlamydia from rectal samples and compare the results between standard culture and newer technology (nucleic acid amplification testing otherwise know as "NAAT") used to detect these infections. Gonorrhea and Chlamydia are STIs (infections you get from having sex with someone who is infected). Infections in the rectum may cause symptoms such as rectal discharge, itching and/or pain or may be asymptomatic (no symptoms present). Since these infections are sexually transmitted, it is important to have accurate tests to diagnose and treat these infections to prevent them from being passed onto a sexual partner.
NAAT has not been Food and Drug Administration (FDA) approved for use in diagnosing these infections in the rectum. The tests are approved to detect these infections from other sites (cervix and urine) and investigators believe that these tests will be very accurate in detecting these infections in the rectum as well. This study will validate the use of NAAT in rectal samples so that this technology can be used in our research laboratory for future studies that involve testing for STIs from the rectum.
There are times when people have signs of inflammation in the rectum (known as proctitis) and an infection or cause is not able to be identified. Investigators believe that this new technology (NAAT) may be able to find reasons (different bacteria) for infection that were not able to be identified with older testing methods. By participating in this study, one of the rectal swabs will also be tested for additional bacteria (called Mycoplasma and Trichomonas). Both of these organisms are sexually transmitted and may be important organisms in the cause of proctitis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women (n=175) and men who have sex with men (n=224) with a lifetime history of anal intercourse by self-report
Key inclusion criteria (3 listed)
- Male and female subjects 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 (2 listed)
- Use of oral antibiotics in the past 7 days
- Use of rectal douche or other rectal 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 |
|---|---|---|
| Gen-Probe APTIMA Combo2 (AC2)Laboratory Test | Other | – |
Primary outcome
Sensitivity and specificity of AC2 in detecting Neisseria gonorrhoeae in rectal samples
Time frame: Visit 1
Sensitivity and specificity of AC2 to ProbeTec and culture in detecting Neisseria gonorrhoeae in rectal samples
Sensitivity and specificity of AC2 in detecting Chlamydia trachomatis in rectal samples
Time frame: Visit 1
Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting Chlamydia trachomatis in rectal sample
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 17 Aug 2016.
- 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.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
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 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 17 Aug 2016. 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?
Sensitivity and specificity of AC2 in detecting Neisseria gonorrhoeae in rectal samples (time frame: Visit 1). The study lists 2 primary outcomes in all. 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 17 Aug 2016.