Expired Study
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San Francisco, California 94103


Purpose:

Julius Schachter, PhD, from the Department of Laboratory Medicine at UCSF, and Jeffrey Klausner, MD, from the Department of Public Health, are conducting a study to evaluate a type of test (nucleic acid amplification test) for the detection of two sexually transmitted diseases, Chlamydia trachomatis and Neisseria gonorrhoeae, in men who have sex with men (MSM), using urine samples and swabs taken from the throat (pharynx), tip of penis (glans), and rectum. The use of nucleic acid amplification tests on these swabs is experimental, which means that the use of the tests for this purpose have not been approved by the Food & Drug Administration.


Study summary:

For all subjects 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, three clinician-collected pharyngeal, four rectal swabs (three clinician-collected, 1 self-collected) specimens, one glans swab (self-collected) and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician collected swabs will be randomized. Three pharyngeal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG (TMA, SDA) and CT culture at UCSF. Four rectal swabs will be tested for: 1) CT/NG NAAT (TMA) at DPH, 2) NG culture at DPH and 3) NAATs for CT/NG on Clinician- and self-collected rectal swab (TMA, SDA) and CT culture at UCSF. Self-collected glans swab and the FCU will be tested by NAATs for CT/NG (TMA, SDA) at UCSF. All NAAT specimens collected in a universal NAAT transport medium. After specimen processing, samples will be frozen at -70 C for discrepant analysis.


Criteria:

Inclusion Criteria: - A subject must be a man who has sex with men (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, 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.


Study is Available At:


Original ID:

H1079-26791-01


NCT ID:

NCT00187902


Secondary ID:


Study Acronym:


Brief Title:

Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM


Official Title:

Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: C


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

907


Enrollment Type:

Actual


Overall Contact Information

Official Name:Julius Schachter, PhD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:October 2005
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 13, 2011
First Received Date:September 15, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae.
Time Frame:At enrollment/screening
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Samples and Retentions

Sample Retention:Samples With DNA
Description: self-collected glans swab; clinician-collected rectal and pharyngeal swabs
Study Population: Men who have sex with men (MSM) voluntarily presenting at the City STD clinic.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:3084665
Reference Type:Reference
Citation:Schachter J. DFA, EIA, PCR, LCR and other technologies: what tests should be used for diagnosis of chlamydia infections? Immunol Invest. 1997 Jan-Feb;26(1-2):157-61. Review.
PMID:9037620
Reference Type:Reference
Citation:Ostergaard L, Agner T, Krarup E, Johansen UB, Weismann K, Gutschik E. PCR for detection of Chlamydia trachomatis in endocervical, urethral, rectal, and pharyngeal swab samples obtained from patients attending an STD clinic. Genitourin Med. 1997 Dec;73(6):493-7.
PMID:9582468
Reference Type:Reference
Citation:Moncada J, Chernesky M, McCormack W, Schachter J. Evaluation of the Gen-Probe Amplified Chlamydia trachomatis Assay on self-collected vaginal swabs from asymptomatic young females. In: Stephens RS, Byrne GI, Christiansen G, Clarke IN, Grayston JT, Rank RG, et al., editors. Chlamydial Infections: Proceedings of the Ninth International Symposium on Human Chlamydial Infection. San Francisco: International Chlamydia Symposium, 1998:595-8.
Reference Type:Reference
Citation:Centers for Disease Control and Prevention (CDC). High prevalence of chlamydial and gonococcal infection in women entering jails and juvenile detention centers--Chicago, Birmingham, and San Francisco, 1998. MMWR Morb Mortal Wkly Rep. 1999 Sep 17;48(36):793-6.
PMID:10499782
Reference Type:Reference
Citation: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.
PMID:10821595
Reference Type:Reference
Citation: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.
PMID:11230419
Reference Type:Reference
Citation: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. Epub 2001 Dec 7.
PMID:11740704
Reference Type:Reference
Citation:[No authors listed] Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 May 10;51(RR-6):1-78.
PMID:12184549
Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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