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Abbott Molecular stopped funding of study
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| Name | Class |
|---|---|
| Abbott Molecular | INDUSTRY |
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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.
For each subject 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, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician-collected swabs will be randomized.
Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2® [AC2](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG [RealTime](Abbott Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory using: 1) AC2; and 2) RealTime.
A first-catch urine [FCU] specimen will be split out at San Francisco Department of Public Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2; and 2) RealTime.
All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium. After specimen processing, samples will be frozen at -70ºC for discrepant analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Men who have sex with men (MSM) voluntarily presenting at the City STD clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Julius Schachter, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SF City Clinic | San Francisco | California | 94103 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12418541 | Background | 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. | |
| 21160459 | Background |
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Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Men Who Have Sex With Men | The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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clinician-collected rectal and pharyngeal swabs along with FCUs
| San Francisco |
| California |
| 94143 |
| United States |
| 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. |
| 11740704 | 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. |
| 11230419 | 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. |
| 10821595 | 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. |
| 3084665 | 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. |
| 15634960 | 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. |
| 18520976 | 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. |
| 15937765 | 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. |
| 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 |
| 19369445 | 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. |
| 20668135 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Men who have sex with men
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| ID | Title | Description |
|---|---|---|
| BG000 | Men Who Have Sex With Men | The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | per protocol | Posted | Number | Positive test result | 1 day - (At clinic visit) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Men Who Have Sex With Men | The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs. | 0 | 0 | 0 | 0 |
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Our limitations are small number of subjects enrolled due to early termination of the study and we had no pharyngeal CT infections.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julius Schachter, Professor of Laboratory Medicine | University of California, San Francisco | 415 824 5115 | julius.schachter@ucsf.edu |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
| Rectum tested by AC2 for NG |
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| FCU tested by RealTime for NG |
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| FCU tested by AC2 for NG |
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| Oropharynx tested by RealTime for CT |
|
| Oropharynx tested by AC2 for CT |
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| Rectum tested by RealTime for CT |
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| Rectum tested by AC2 for CT |
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| FCU tested by RealTime for CT |
|
| FCU tested by AC2 for CT |
|