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NCT06369220 · ClinicalTrials.gov registry record · NA
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
A NA study of Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- NA
- Development phase
- 344
- Enrollment target
- 4
- Study locations
NCT06369220: Completed NA study of Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, sponsored by Hoffmann-La Roche.
NCT06369220 is a NA study of Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection that has completed, run by Hoffmann-La Roche. The registered enrollment target is 344 participants, below the 1,624-participant average among 3 other Neisseria Gonorrhoeae Infection trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06369220, a NA study of Neisseria Gonorrhoeae Infection and Chlamydia Trachomatis Infection, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- NA
- Development phase
- 344 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
Primary Outcome
An inappropriate treatment was defined as under and/or overtreatment on the day of the medical encounter based on the CDC recommendations for the pathogen-specific results obtained by the EL-PCR testing. Overtreatment was defined by the provision of 2 or more antibiotics when only 1 is necessary, or provision of any unnecessary antibiotics. Undertreatment was defined by failure to provide pathogen-appropriate antimicrobials either alone or in combination.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST cobas® liat CT/NG/MG nucleic acid test
- OTHER Standard of Care (SOC): Clinician's Standard Practice
Study Locations (4)
New Jersey
- Planned Parenthood of Northern, Central, and Southern New Jersey, Inc. - Hamilton Square
- Planned Parenthood of Northern, Central and Southern New Jersey - Perth Amboy
California
- San Francisco City Clinic - San Francisco
Texas
- Baylor Scott & White Health - Kileen - Killeen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2025-05-28 |
| Phase | NA |
What the finished NCT06369220 record still lists
NCT06369220 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 1,624-participant average among 3 other Neisseria Gonorrhoeae Infection trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Neisseria Gonorrhoeae Infection appearing as the primary indexed condition, and to 2 interventions - of which cobas® liat CT/NG/MG nucleic acid test is the first listed.
NCT06369220 reports a single indexed study location in New Jersey, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06369220 about?
NCT06369220 is a clinical study titled "A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections". This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
What is the current status of trial NCT06369220?
This trial is currently completed. It is a NA study. The enrollment target is 344 participants. The study started on 2024-07-29. Estimated completion is 2025-05-28.
What conditions does trial NCT06369220 study?
This clinical trial studies the following conditions: Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Mycoplasma Genitalium Infection.
What interventions are being tested in trial NCT06369220?
The interventions under investigation include: cobas® liat CT/NG/MG nucleic acid test (DIAGNOSTIC_TEST), Standard of Care (SOC): Clinician's Standard Practice (OTHER).
Who is sponsoring clinical trial NCT06369220?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06369220 being conducted?
This trial has 4 study locations across California, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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