Trial record 14 of 4400 for:    "Sexually Transmitted Diseases"

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

This study has been terminated.
(Abbott Molecular stopped funding of study)
Sponsor:
Collaborator:
Abbott Molecular
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01291264
First received: February 1, 2011
Last updated: January 21, 2014
Last verified: January 2014
  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.


Condition Phase
Chlamydia Infection
Gonococcal Infection
Sexually Transmitted Diseases
Phase 4

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]

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Enrollment: 260
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men who have sex with men (MSM) voluntarily presenting at the City STD clinic.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291264

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
SF City Clinic
San Francisco, California, United States, 94103
Sponsors and Collaborators
University of California, San Francisco
Abbott Molecular
Investigators
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
Results First Received: January 21, 2014
Last Updated: January 21, 2014
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:
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 11, 2014