Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]
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Purpose
Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG], using urine samples and swabs from the throat and rectum of men who have sex with men [MSM]. Using this test on these swabs is experimental because it has not been approved by the Food & Drug Administration.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Evaluation of Abbott RealTime CT/NG for the Detection of Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] From the Pharynx, Rectum & Urethra of Men Who Have Sex With Men [MSM] |
- Subject's infected-status as determined by the nucleic acid amplification assays performed. [ Time Frame: 1 day - (At clinic visit) ] [ Designated as safety issue: No ]This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.
Biospecimen Retention: Samples With DNA
clinician-collected rectal and pharyngeal swabs along with FCUs
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
For each subject enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.
For each subject enrolled in the study, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician-collected swabs will be randomized.
Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2® [AC2](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG [RealTime](Abbott Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory using: 1) AC2; and 2) RealTime.
A first-catch urine [FCU] specimen will be split out at San Francisco Department of Public Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2; and 2) RealTime.
All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium. After specimen processing, samples will be frozen at -70ºC for discrepant analysis.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Men who have sex with men (MSM) voluntarily presenting at the City STD clinic.
Inclusion Criteria:
- A subject must be MSM. Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.
Exclusion Criteria:
- Subjects are excluded if they do not have sex with men, refuse to give verbal consent or refuse to allow such consent to be documented in their chart, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
Contacts and Locations| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Julius Schachter, PhD 415-824-5115 Julius.Schachter@ucsf.edu | |
| Principal Investigator: Julius Schachter, PhD | |
| SF City Clinic | Recruiting |
| San Francisco, California, United States, 94103 | |
| Contact: Susan S Philip, MD, MPH 415-487-5500 Susan.Philip@sfdph.org | |
| Principal Investigator: Susan S Philip, MD, MPH | |
| Principal Investigator: | Julius Schachter, PhD | University of California, San Francisco |
More Information
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01291264 History of Changes |
| Other Study ID Numbers: | 10-04134 |
| Study First Received: | February 1, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Chlamydia trachomatis Neisseria gonorrhoeae Sexually Transmitted Diseases |
Additional relevant MeSH terms:
|
Chlamydia Infections Gonorrhea Sexually Transmitted Diseases Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Sexually Transmitted Diseases, Bacterial Infection Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013