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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
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
Conditions
Interventions
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.
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