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

NCT01291264 | Terminated Results

• 1 other identifier: 10-04134
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Chlamydia Infection; Gonococcal Infection; Sexually Transmitted Diseases

Keywords

Chlamydia trachomatis; Neisseria gonorrhoeae; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

• Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.

  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.

  1 day - (At clinic visit)

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Abbott Molecular: collaborator

Study Sites (2)

SF City Clinic

San Francisco, California, 94103, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (12)

• Johnson RE, Newhall WJ, Papp JR, Knapp JS, Black CM, Gift TL, Steece R, Markowitz LE, Devine OJ, Walsh CM, Wang S, Gunter DC, Irwin KL, DeLisle S, Berman SM. Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections--2002. MMWR Recomm Rep. 2002 Oct 18;51(RR-15):1-38; quiz CE1-4.

  PMID: 12418541 BACKGROUND

• Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):1-110.

  PMID: 21160459 BACKGROUND

• Page-Shafer K, Graves A, Kent C, Balls JE, Zapitz VM, Klausner JD. Increased sensitivity of DNA amplification testing for the detection of pharyngeal gonorrhea in men who have sex with men. Clin Infect Dis. 2002 Jan 15;34(2):173-6. doi: 10.1086/338236. Epub 2001 Dec 7.

  PMID: 11740704 BACKGROUND

• Van Der Pol B, Ferrero DV, Buck-Barrington L, Hook E 3rd, Lenderman C, Quinn T, Gaydos CA, Lovchik J, Schachter J, Moncada J, Hall G, Tuohy MJ, Jones RB. Multicenter evaluation of the BDProbeTec ET System for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs. J Clin Microbiol. 2001 Mar;39(3):1008-16. doi: 10.1128/JCM.39.3.1008-1016.2001.

  PMID: 11230419 BACKGROUND

• Ciemins EL, Flood J, Kent CK, Shaw H, Rowniak S, Moncada J, Klausner JD, Schachter J. Reexamining the prevalence of Chlamydia trachomatis infection among gay men with urethritis: implications for STD policy and HIV prevention activities. Sex Transm Dis. 2000 May;27(5):249-51. doi: 10.1097/00007435-200005000-00002.

  PMID: 10821595 BACKGROUND

• Rompalo AM, Price CB, Roberts PL, Stamm WE. Potential value of rectal-screening cultures for Chlamydia trachomatis in homosexual men. J Infect Dis. 1986 May;153(5):888-92. doi: 10.1093/infdis/153.5.888.

  PMID: 3084665 BACKGROUND

• Chernesky MA, Martin DH, Hook EW, Willis D, Jordan J, Wang S, Lane JR, Fuller D, Schachter J. Ability of new APTIMA CT and APTIMA GC assays to detect Chlamydia trachomatis and Neisseria gonorrhoeae in male urine and urethral swabs. J Clin Microbiol. 2005 Jan;43(1):127-31. doi: 10.1128/JCM.43.1.127-131.2005.

  PMID: 15634960 BACKGROUND

• Schachter J, Moncada J, Liska S, Shayevich C, Klausner JD. Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis. 2008 Jul;35(7):637-42. doi: 10.1097/OLQ.0b013e31817bdd7e.

  PMID: 18520976 BACKGROUND

• Kent CK, Chaw JK, Wong W, Liska S, Gibson S, Hubbard G, Klausner JD. Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis. 2005 Jul 1;41(1):67-74. doi: 10.1086/430704. Epub 2005 May 26.

  PMID: 15937765 BACKGROUND

• Laboratory Diagnostic Testing for Chlamydia trachomatis and Neisseria gonorrhoeae. American Public Health Laboratories/Center for Disease Control & Prevention Panel Summary Reports. January 2009. Internet. Accessed 8 November 2010. http://www.aphl.org/aphlprograms/infectious/std/Documents/CTGCLabGuidelinesMeetingReport.pdf

  BACKGROUND

• Moncada J, Schachter J, Liska S, Shayevich C, Klausner JD. Evaluation of self-collected glans and rectal swabs from men who have sex with men for detection of Chlamydia trachomatis and Neisseria gonorrhoeae by use of nucleic acid amplification tests. J Clin Microbiol. 2009 Jun;47(6):1657-62. doi: 10.1128/JCM.02269-08. Epub 2009 Apr 15.

  PMID: 19369445 BACKGROUND

• Gaydos CA, Cartwright CP, Colaninno P, Welsch J, Holden J, Ho SY, Webb EM, Anderson C, Bertuzis R, Zhang L, Miller T, Leckie G, Abravaya K, Robinson J. Performance of the Abbott RealTime CT/NG for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2010 Sep;48(9):3236-43. doi: 10.1128/JCM.01019-10. Epub 2010 Jul 28.

  PMID: 20668135 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

clinician-collected rectal and pharyngeal swabs along with FCUs

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our limitations are small number of subjects enrolled due to early termination of the study and we had no pharyngeal CT infections.

Results Point of Contact

• Title: Dr. Julius Schachter, Professor of Laboratory Medicine
• Organization: University of California, San Francisco

julius.schachter@ucsf.edu

415 824 5115

Study Officials

• Julius Schachter, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 8, 2011
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 4, 2014
• Results First Posted: March 4, 2014

Record last verified: 2014-01

Locations

US (2)