A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples

NCT00827697 | Completed

• 3 other identifiers: PRO08120504UM1AI0686335UM1AI106707
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Gonorrhea; Chlamydia

Keywords

Gonorrhea; Chlamydia; Rectal

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Visit 1

Interventions

Gen-Probe APTIMA Combo2 (AC2) OTHER

Laboratory Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women (n=175) and men who have sex with men (n=224) with a lifetime history of anal intercourse by self-report

You may qualify if:

• 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

You may not qualify if:

• Use of oral antibiotics in the past 7 days
• Use of rectal douche or other rectal product in the past 24 hours

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Pittsburgh AIDS Center for Treatment (PACT)

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Richard Sweet Professor of Reproductive Infectious Disease

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 23, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)