Neisseria Gonorrhoeae InfectionpNAATNCT02870101

Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT

A study testing 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 in people with Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, run by Duke University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Sexually Transmitted Infections
What is being tested?: 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,767 participants
Where: 9 sitesUnited States
Study dates: 10 Apr 2017to 12 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Receipt of any systemic antibacterial drug in the past 14 days
Receipt of myelosuppressive chemotherapy in the past 30 days

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Central Texas Clinical Research
Austin, Texas, 78705
Denver Health and Hospital Authority
Denver, Colorado, 80204
Wayne State University
Detroit, Michigan, 48201
AIDS Health Foundation - Hollywood
Hollywood, California, 90028
Los Angeles LGBT Clinic
Los Angeles, California, 90028
AIDS Healthcare Foundation - Miami
Miami, Florida, 33133
University of Miami
Miami, Florida, 33136
Louisiana State University
New Orleans, Louisiana, 70119
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites

The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.

Read the 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.

Conditions: Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Sexually Transmitted Infections
Being tested: Nucleic acid amplification test 1 for NG and CT, Nucleic acid amplification test 2 for NG and CT, Nucleic acid amplification test 3 for NG and CT
Keywords: Nucleic acid amplification tests, Neisseria gonorrhoeae infection, Chlamydia trachomatis infection, Sexually transmitted infection, Pharynx, Rectum, Gram-Negative Bacterial Infections, Bacterial Infections, Genital Diseases, Male, Genital Diseases, Female
Medical subject headings: Gonorrhea, Sexually Transmitted Diseases, Gram-Negative Bacterial Infections, Bacterial Infections, Genital Diseases, Male, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nucleic acid amplification test 1 for NG and CTDiagnostic test
A combination test using real-time PCR to detect DNA from NG and CT.
Nucleic acid amplification test 2 for NG and CTDiagnostic test
A combination test using target amplification to detect RNA from NG and CT.
Nucleic acid amplification test 3 for NG and CTDiagnostic test
A combination test using real-time PCR to detect DNA from NG and CT.

Study groups in NCT02870101
Study group	Role	What they receive
Intervention	Other	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. Receives: Diagnostic Test: Nucleic acid amplification test 1 for NG and CT; Diagnostic Test: Nucleic acid amplification test 2 for NG and CT; Diagnostic Test: Nucleic acid amplification test 3 for NG and CT

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201712 Mar 2018

First posted17 Aug 2016 (estimated)
Study start10 Apr 2017
Primary completion12 Mar 2018
Study completion12 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Neisseria Gonorrhoeae InfectionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,767 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02870101
Sponsor's protocol ID: Pro00073558
Other IDs: 5UM1AI104681
Acronym: pNAAT
Status last verified: May 2019
First submitted: 12 Aug 2016
Last updated: 15 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 24005255
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.
PubMed 6415361
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.
PubMed 1411832
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.
PubMed 11689757
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.
PubMed 22700700
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.
PubMed 26042815
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.
PubMed 25244000
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.
PubMed 19126571
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.
PubMed 18520976
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.
PubMed 25868133
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.
PubMed 20335410
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.
PubMed 22493338
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.
PubMed 23891224
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.
PubMed 19369445
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.
PubMed 24653040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection

All Neisseria Gonorrhoeae Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia Trachomatis in Extragenital Sites
ClinicalTrials.gov ID: NCT02870101
Acronym / sponsor ID: pNAAT / Pro00073558
Conditions: Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Sexually Transmitted Infections
Keywords: Nucleic acid amplification tests, Neisseria gonorrhoeae infection, Chlamydia trachomatis infection, Sexually transmitted infection, Pharynx, Rectum, Gram-Negative Bacterial Infections, Bacterial Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,767 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 10 Apr 2017 (actual)
Primary completion: 12 Mar 2018 (actual)
Study completion: 12 Mar 2018 (actual)
First posted: 17 Aug 2016 (estimated)
Results: Posted 26 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Other	Diagnostic Test: Nucleic acid amplification test 1 for NG and CT, Diagnostic Test: Nucleic acid amplification test 2 for NG and CT, Diagnostic Test: Nucleic acid amplification test 3 for NG and CTPerformance 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

Receipt of any systemic antibacterial drug in the past 14 days
Receipt of myelosuppressive chemotherapy in the past 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nucleic acid amplification test 1 for NG and CTA combination test using real-time PCR to detect DNA from NG and CT.	Diagnostic test	Intervention
Nucleic acid amplification test 2 for NG and CTA combination test using target amplification to detect RNA from NG and CT.	Diagnostic test	Intervention
Nucleic acid amplification test 3 for NG and CTA combination test using real-time PCR to detect DNA from NG and CT.	Diagnostic test	Intervention

Primary outcome

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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 26 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	2,767	2,598

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Intervention n = 2590
Index Test Negative; ASIS Negative	2340
Index Test Negative; ASIS Positive	9
Index Test Negative; ASIS Indeterminate	2
Index Test Negative; ASIS Invalid	1
Index Test Positive; ASIS Negative	28
Index Test Positive; ASIS Positive	195
Index Test Positive; ASIS Indeterminate	1
Index Test Positive; ASIS Invalid	1

Intervention: PPA: 94.7 (95% CI 90.7 to 97.0)
Intervention: NPA: 98.8 (95% CI 98.2 to 99.1)

Population analysed: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Intervention n = 2585
Index Test Negative; ASIS Negative	2323
Index Test Negative; ASIS Positive	17
Index Test Negative; ASIS Indeterminate	1
Index Test Negative; ASIS Invalid	2
Index Test Positive; ASIS Negative	8
Index Test Positive; ASIS Positive	187
Index Test Positive; ASIS Indeterminate	1
Index Test Positive; ASIS Invalid	0

Intervention: PPA: 91.2 (95% CI 86.5 to 94.4)
Intervention: NPA: 99.6 (95% CI 99.3 to 99.8)

Population analysed: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Intervention n = 2590
Index Test Negative; ASIS Negative	2351
Index Test Negative; ASIS Positive	8
Index Test Negative; ASIS Indeterminate	2
Index Test Negative; ASIS Invalid	2
Index Test Positive; ASIS Negative	25
Index Test Positive; ASIS Positive	195
Index Test Positive; ASIS Indeterminate	1
Index Test Positive; ASIS Invalid	0

Intervention: PPA: 95.1 (95% CI 91.3 to 97.3)
Intervention: NPA: 98.8 (95% CI 98.3 to 99.2)

Population analysed: Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Intervention n = 2585
Index Test Negative; ASIS Negative	2359
Index Test Negative; ASIS Positive	5
Index Test Negative; ASIS Indeterminate	0
Index Test Negative; ASIS Invalid	3
Index Test Positive; ASIS Negative	13
Index Test Positive; ASIS Positive	192
Index Test Positive; ASIS Indeterminate	2
Index Test Positive; ASIS Invalid	0

Intervention: PPA: 96.5 (95% CI 92.9 to 98.3)
Intervention: NPA: 99.2 (95% CI 98.8 to 99.5)

Population analysed: Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.

Adverse events

Time frame: One day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 2,598 (0%)	0 of 2,598 (0%)	0 of 2,598

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24005255Liu 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.
Background: PubMed 6415361O'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.
Background: PubMed 1411832Westrom 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.
Background: PubMed 11689757Rottingen 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.
Background: PubMed 22700700Deguchi 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.
Background: PubMed 26042815Workowski 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.
Background: PubMed 25244000Zakher 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.
Background: PubMed 19126571Ota 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.
Background: PubMed 18520976Schachter 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.
Background: PubMed 25868133Trebach 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.
Background: PubMed 20335410Bachmann 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.
Background: PubMed 22493338Cosentino 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey D Klausner, MD, MPH principal investigator

UCLA David Geffen School of Medicine and Fielding School of Public Health

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870101, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.