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

NCT02870101 | Completed Results FDA Device

• 2 other identifiers: Pro000735585UM1AI104681
• Study Type: interventional
• Target: 2,767
• Locations: 1 country
• Sites: 9

Brief Summary

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

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; Genital Diseases, Male; Genital Diseases, Female

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  One day

Study Arms (1)

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.

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

Interventions

Nucleic acid amplification test 1 for NG and CT DIAGNOSTIC_TEST

A combination test using real-time PCR to detect DNA from NG and CT.

Intervention

Nucleic acid amplification test 2 for NG and CT DIAGNOSTIC_TEST

A combination test using target amplification to detect RNA from NG and CT.

Intervention

Nucleic acid amplification test 3 for NG and CT DIAGNOSTIC_TEST

A combination test using real-time PCR to detect DNA from NG and CT.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (9)

AIDS Health Foundation - Hollywood

Hollywood, California, 90028, United States

Location

Los Angeles LGBT Clinic

Los Angeles, California, 90028, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

AIDS Healthcare Foundation - Miami

Miami, Florida, 33133, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Louisiana State University

New Orleans, Louisiana, 70119, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Related Publications (23)

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  PMID: 31734695 DERIVED

MeSH Terms

Conditions

Gonorrhea; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Genital Diseases, Male; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Jeffrey D. Klausner, MD, MPH
• Organization: UCLA David Geffen School of Medicine and Fielding School of Public Health

JDKlausner@mednet.ucla.edu

310-557-2273

Study Officials

• Jeffrey D Klausner, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All information collected anonymously.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: April 10, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: May 15, 2019
• Results First Posted: April 26, 2019

Record last verified: 2019-05

Locations

US (9)