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

13 april 2011 bijgewerkt door: University of California, San Francisco

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

907

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- California
  - San Francisco, California, Verenigde Staten, 94103
    - City Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Positive nucleic acid amplification result for Chlamydia trachomatis or Neisseria gonorrhoeae. Tijdsspanne: At enrollment/screening	At enrollment/screening

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Francisco

Onderzoekers

Hoofdonderzoeker: Jeffrey D Klausner, MD, MPH, Department of Public Health, San Francisco, CA USA

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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.
Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 May 10;51(RR-6):1-78.
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.
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.
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.
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.
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.
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. doi: 10.1136/sti.73.6.493.
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. doi: 10.3109/08820139709048923.
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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2005

Primaire voltooiing (Werkelijk)

1 mei 2007

Studie voltooiing (Werkelijk)

1 december 2008

Studieregistratiedata

Eerst ingediend

15 september 2005

Eerst ingediend dat voldeed aan de QC-criteria