N/A
N=2,767
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
Neisseria Gonorrhoeae Infection · Chlamydia Trachomatis Infection · Sexually Transmitted Infections
Bottom Line
View on ClinicalTrials.gov: NCT02870101 ↗Enrolled (actual)
2,767
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: 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 — 2340; 9; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2340; 9; 2; 1; 28; 195 | — |
| PRIMARY 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 |
2323; 17; 1; 2; 8; 187 | — |
| PRIMARY 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 |
2351; 8; 2; 2; 25; 195 | — |
| PRIMARY 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 |
2359; 5; 0; 3; 13; 192 | — |
| PRIMARY 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 |
2356; 28; 4; 1; 11; 179 | — |
| PRIMARY 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 |
2312; 23; 1; 1; 8; 181 | — |
| PRIMARY 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 |
2518; 2; 0; 2; 6; 47 | — |
| PRIMARY 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 |
2292; 28; 4; 2; 15; 197 | — |
| PRIMARY 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 |
2526; 6; 0; 2; 8; 45 | — |
| PRIMARY 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 |
2322; 18; 2; 3; 25; 197 | — |
| PRIMARY 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 |
2522; 8; 0; 2; 4; 42 | — |
| PRIMARY 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 |
2277; 34; 5; 1; 19; 190 | — |
Summary
The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02870101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.