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COMPLETED
NCT06369220
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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

331

Start Date

2024-07-29

Completion Date

2025-05-28

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

cobas® liat CT/NG/MG nucleic acid test

The cobas® CT/NG/MG nucleic acid test for use on the cobas® Liat® System is an investigational, automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs (clinician-collected and self-collected) in cobas® PCR Media.

OTHER

Standard of Care (SOC): Clinician's Standard Practice

Standard of care (SOC) is defined as the traditional/typical diagnosis and treatment steps in practice recommended by the CDC guidelines that rely upon clinical syndromic presentations and/or external laboratory testing.

Locations (4)

San Francisco City Clinic

San Francisco, California, United States

Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.

Hamilton Square, New Jersey, United States

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, United States

Baylor Scott & White Health - Kileen

Killeen, Texas, United States