CompletedNot Applicable

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

United States2,767 participantsStarted 2017-04-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: One day

Trial details

NCT IDNCT02870101

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-12

Results submitted2019-04-04

View on ClinicalTrials.gov More Neisseria Gonorrhoeae Infection trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: One day