Nucleic Acid Amplification Tests (NAATs) for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections

NCT00252096 | Completed

• 3 other identifiers: CDC-NCHSTP-3881CA U36/CCU300430 PA05048ASPH S2070-22/22
• Study Type: interventional
• Target: 3,900
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators at the University of Alabama in Birmingham in collaboration with investigators from the Centers for Disease Control in Atlanta are evaluating the performance of three commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in pharyngeal and rectal swab specimens. Cultures for C. trachomatis and N. gonorrhoeae are performed as additional reference tests. Study subjects are men and women attending sexually transmitted disease (STD) and HIV care clinics in Birmingham, Alabama, who report sexual behaviors that place them at risk for pharyngeal or rectal sexually transmitted infections.

Conditions

Chlamydia Infections; Gonorrhea

Keywords

Diagnosis; Chlamydia trachomatis; Neisseria gonorrhoeae; Nucleic acid amplification test; Rectum; Pharynx

Outcome Measures

Primary Outcomes (1)

• Detection of Chlamydia trachomatis or Neisseria gonorrhoeae infections

Interventions

Nucleic acid amplification test DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 15 years.
• If male, history of fellatio, cunnilingus, or receptive anal sex within the last two months.
• If female, presenting for treatment of N. gonorrhoeae and/or C. trachomatis or contact to N. gonorrhoeae, C. trachomatis, or nongonococcal urethritis.
• If female, history of fellatio or history of anal sex within the last two months.

You may not qualify if:

• Declines to participate.
• History of receipt of antimicrobial agents active against N. gonorrhoeae or C. trachomatis in the preceding 30 days.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea; Disease

Interventions

Nucleic Acid Amplification Techniques

Condition Hierarchy (Ancestors)

Chlamydiaceae 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; Neisseriaceae Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques

Study Officials

• Laura H. Bachmann, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Edward W. Hook, III, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: June 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: June 1, 2010
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)