At a glance
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A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
In Brief
A clinical study evaluating cobas® liat CT/NG/MG nucleic acid test and Standard of Care (SOC): Clinician's Standard Practice for Chlamydia Trachomatis Infection and 2 related conditions. Completed, enrolled 331 participants across 4 sites.
Signals
Detailed 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).
Study Details
Timeline
Arms & Interventions
In the SOC arm, the clinician will evaluate the participant based on standard practice.
In the POC arm, the clinician will evaluate the participant and will be provided POC test results upon which they may choose to base their clinical decisions.
Interventions
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) 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.