- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870101
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT (pNAAT)
Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites
Study Overview
Status
Conditions
Detailed Description
Background & Significance: Infections due to Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) are major threats to public health. Most CT and NG infections are asymptomatic, but infection can lead to serious sequelae, including infertility, chronic pelvic pain, adverse obstetrical outcomes, increased risk of acquiring the human immunodeficiency virus (HIV), and disseminated infection.
There has also been growing concern over antibiotic resistance. In 2013, the US Centers for Disease Control and Prevention (CDC) classified drug-resistant NG as one of the three urgent-level resistant bacteria. Improved detection of extragenital NG is thought to be a crucial component of adequate treatment and for prevention of further resistance.
Currently, the CDC recommends using NAATs to screen and diagnose for NG and CT in the genitourinary tract due to their superior sensitivity compared to traditional culture methods. There are currently no FDA-approved commercial NAAT tests for the detection of pharyngeal and rectal NG or CT infections. The goal of this study is to evaluate the diagnostic performance of three NAAT assays for detection of extragenital NG and CT infections.
Design & Procedures: A cross-sectional, single visit study evaluating the performance of three commercial NAATs to detect NG and CT in the rectum and pharynx. A fourth NAAT will be used as a tiebreaker. The performance of the fourth NAAT will not be evaluated. Each manufacturer will provide a specific swab collection kit and transport media.
This research study will take place at healthcare clinics that focus on sexually transmitted infections, women's health, student health, family planning, and lesbian, gay, bisexual, and transgender (LGBT) health. This research will include specimens collected from adult males, females, and transgender persons seeking sexually transmitted infection (STI) testing at the participating study clinics. Both symptomatic and asymptomatic participants are included in the study population.
Potential participants will be identified, assessed for eligibility, and asked to provide oral informed consent. If a potential participant agrees to take part in the research, the participant will have eight total swabs collected: four swabs from the pharynx and four swabs from the rectum. The swabs needed for routine clinical care are taken first prior to collection of the research study swabs. All study procedures take place during one clinic visit; there are no follow-up visits as part of the study. Participants continue with routine clinical care as directed by their medical providers.
Subject participation is confidential and anonymous. The results of the tests and participation in this research are not placed in the participant's medical records.
Each study swab is used for a specific NAAT and tested at one of the two reference testing laboratories. The Anatomic Site Infection Status (ASIS) is defined by the results of the two other NAATs, and, if necessary, results from the tiebreaker NAAT. Each anatomic site is considered in isolation. If fewer than four swabs at an anatomic site are completed, then the test results from that specific anatomic site are excluded from analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Hollywood, California, United States, 90028
- AIDS Health Foundation - Hollywood
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Los Angeles, California, United States, 90028
- Los Angeles LGBT Clinic
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health and Hospital Authority
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Miami, Florida, United States, 33133
- AIDS Healthcare Foundation - Miami
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Louisiana
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New Orleans, Louisiana, United States, 70119
- Louisiana State University
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Texas
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Austin, Texas, United States, 78705
- Central Texas Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Attending a participating clinic for evaluation of sexually transmitted infections (STIs)
- ≥18 years of age at date of screening
- Able and willing to provide informed consent
- Willing to comply with study procedures, including collection of 4 swabs each from the pharynx and rectum for NG and CT testing
Exclusion Criteria:
- Receipt of any systemic antibacterial drug in the past 14 days
- Receipt of myelosuppressive chemotherapy in the past 30 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
Performance of three nucleic acid amplification tests (NAATs) to detect Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) from swabs collected from the pharynx and rectum.
Assays include: Nucleic acid amplification test 1 for NG and CT; Nucleic acid amplification test 2 for NG and CT; and, Nucleic acid amplification test 3 for NG and CT.
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A combination test using real-time PCR to detect DNA from NG and CT.
A combination test using target amplification to detect RNA from NG and CT.
A combination test using real-time PCR to detect DNA from NG and CT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Time Frame: One day
|
NAAT 1 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
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One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Time Frame: One day
|
NAAT 1 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Time Frame: One day
|
NAAT 2 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Time Frame: One day
|
NAAT 2 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx
Time Frame: One day
|
NAAT 3 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum
Time Frame: One day
|
NAAT 3 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Time Frame: One day
|
NAAT 1 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Time Frame: One day
|
NAAT 1 index test results include negative, positive, and no result.
ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Time Frame: One day
|
NAAT 2 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Time Frame: One day
|
NAAT 2 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx
Time Frame: One day
|
NAAT 3 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum
Time Frame: One day
|
NAAT 3 index test results include negative, positive, equivocal, and no result.
ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results.
ASIS reference results include negative, positive, indeterminate, and invalid.
|
One day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey D Klausner, MD, MPH, UCLA David Geffen School of Medicine and Fielding School of Public Health
Publications and helpful links
General Publications
- Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137. Erratum In: MMWR Recomm Rep. 2015 Aug 28;64(33):924.
- Liu B, Roberts CL, Clarke M, Jorm L, Hunt J, Ward J. Chlamydia and gonorrhoea infections and the risk of adverse obstetric outcomes: a retrospective cohort study. Sex Transm Infect. 2013 Dec;89(8):672-8. doi: 10.1136/sextrans-2013-051118. Epub 2013 Sep 4.
- O'Brien JP, Goldenberg DL, Rice PA. Disseminated gonococcal infection: a prospective analysis of 49 patients and a review of pathophysiology and immune mechanisms. Medicine (Baltimore). 1983 Nov;62(6):395-406.
- Westrom L, Joesoef R, Reynolds G, Hagdu A, Thompson SE. Pelvic inflammatory disease and fertility. A cohort study of 1,844 women with laparoscopically verified disease and 657 control women with normal laparoscopic results. Sex Transm Dis. 1992 Jul-Aug;19(4):185-92.
- Rottingen JA, Cameron DW, Garnett GP. A systematic review of the epidemiologic interactions between classic sexually transmitted diseases and HIV: how much really is known? Sex Transm Dis. 2001 Oct;28(10):579-97. doi: 10.1097/00007435-200110000-00005.
- Deguchi T, Yasuda M, Ito S. Management of pharyngeal gonorrhea is crucial to prevent the emergence and spread of antibiotic-resistant Neisseria gonorrhoeae. Antimicrob Agents Chemother. 2012 Jul;56(7):4039-40; author re[ply 4041-2. doi: 10.1128/AAC.00505-12. No abstract available.
- Zakher B, Cantor AG, Pappas M, Daeges M, Nelson HD. Screening for gonorrhea and Chlamydia: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014 Dec 16;161(12):884-93. doi: 10.7326/M14-1022.
- Ota KV, Tamari IE, Smieja M, Jamieson F, Jones KE, Towns L, Juzkiw J, Richardson SE. Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in pharyngeal and rectal specimens using the BD Probetec ET system, the Gen-Probe Aptima Combo 2 assay and culture. Sex Transm Infect. 2009 Jun;85(3):182-6. doi: 10.1136/sti.2008.034140. Epub 2009 Jan 6.
- 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.
- Trebach JD, Chaulk CP, Page KR, Tuddenham S, Ghanem KG. Neisseria gonorrhoeae and Chlamydia trachomatis among women reporting extragenital exposures. Sex Transm Dis. 2015 May;42(5):233-9. doi: 10.1097/OLQ.0000000000000248.
- Bachmann LH, Johnson RE, Cheng H, Markowitz L, Papp JR, Palella FJ Jr, Hook EW 3rd. Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. J Clin Microbiol. 2010 May;48(5):1827-32. doi: 10.1128/JCM.02398-09. Epub 2010 Mar 24.
- Cosentino LA, Campbell T, Jett A, Macio I, Zamborsky T, Cranston RD, Hillier SL. Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections. J Clin Microbiol. 2012 Jun;50(6):2005-8. doi: 10.1128/JCM.00185-12. Epub 2012 Apr 4.
- Geelen TH, Rossen JW, Beerens AM, Poort L, Morre SA, Ritmeester WS, van Kruchten HE, van de Pas MM, Savelkoul PH. Performance of cobas(R) 4800 and m2000 real-time assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen. Diagn Microbiol Infect Dis. 2013 Oct;77(2):101-5. doi: 10.1016/j.diagmicrobio.2013.06.020. Epub 2013 Jul 23.
- 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.
- Perry MD, Jones RN, Corden SA. Is confirmatory testing of Roche cobas 4800 CT/NG test Neisseria gonorrhoeae positive samples required? Comparison of the Roche cobas 4800 CT/NG test with an opa/pap duplex assay for the detection of N gonorrhoeae. Sex Transm Infect. 2014 Jun;90(4):303-8. doi: 10.1136/sextrans-2013-051410. Epub 2014 Mar 20.
- Harryman L, Scofield S, Macleod J, Carrington D, Williams OM, Fernandes A, Horner P. Comparative performance of culture using swabs transported in Amies medium and the Aptima Combo 2 nucleic acid amplification test in detection of Neisseria gonorrhoeae from genital and extra-genital sites: a retrospective study. Sex Transm Infect. 2012 Feb;88(1):27-31. doi: 10.1136/sextrans-2011-050075. Epub 2011 Oct 27.
- Pope CF, Hay P, Alexander S, Capaldi K, Dave J, Sadiq ST, Ison CA, Planche T. Positive predictive value of the Becton Dickinson VIPER system and the ProbeTec GC Q x assay, in extracted mode, for detection of Neisseria gonorrhoeae. Sex Transm Infect. 2010 Nov;86(6):465-9. doi: 10.1136/sti.2010.044065.
- Goldenberg SD, Finn J, Sedudzi E, White JA, Tong CY. Performance of the GeneXpert CT/NG assay compared to that of the Aptima AC2 assay for detection of rectal Chlamydia trachomatis and Neisseria gonorrhoeae by use of residual Aptima Samples. J Clin Microbiol. 2012 Dec;50(12):3867-9. doi: 10.1128/JCM.01930-12. Epub 2012 Sep 19.
- Boyadzhyan B, Yashina T, Yatabe JH, Patnaik M, Hill CS. Comparison of the APTIMA CT and GC assays with the APTIMA combo 2 assay, the Abbott LCx assay, and direct fluorescent-antibody and culture assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2004 Jul;42(7):3089-93. doi: 10.1128/JCM.42.7.3089-3093.2004.
- 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.
- Moncada J, Donegan E, Schachter J. Evaluation of CDC-recommended approaches for confirmatory testing of positive Neisseria gonorrhoeae nucleic acid amplification test results. J Clin Microbiol. 2008 May;46(5):1614-9. doi: 10.1128/JCM.02301-07. Epub 2008 Mar 5.
- Tabrizi SN, Unemo M, Limnios AE, Hogan TR, Hjelmevoll SO, Garland SM, Tapsall J. Evaluation of six commercial nucleic acid amplification tests for detection of Neisseria gonorrhoeae and other Neisseria species. J Clin Microbiol. 2011 Oct;49(10):3610-5. doi: 10.1128/JCM.01217-11. Epub 2011 Aug 3.
- Doernberg SB, Komarow L, Tran TTT, Sund Z, Pandori MW, Jensen D, Tsalik EL, Deal CD, Chambers HF, Fowler VG, Evans SR, Patel R, Klausner JD. Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol. Clin Infect Dis. 2020 Dec 3;71(9):2314-2322. doi: 10.1093/cid/ciz1105.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Infections
- Communicable Diseases
- Chlamydia Infections
- Gonorrhea
- Sexually Transmitted Diseases
Other Study ID Numbers
- Pro00073558
- 5UM1AI104681 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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