Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

NCT ID: NCT01291264

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chlamydia Infection; Gonococcal Infection; Sexually Transmitted Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Molecular

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julius Schachter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

SF City Clinic

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

10-04134

Identifier Type: -

Identifier Source: org_study_id