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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

NCT06369220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2025-06-29

No results posted yet for this 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).

Conditions

  • Chlamydia Trachomatis Infection
  • Neisseria Gonorrhoeae Infection
  • Mycoplasma Genitalium Infection

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.

Sponsors & Collaborators

Principal Investigators

  • Zune Huynh, MD · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-29
Primary Completion
2025-05-28
Completion
2025-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06369220 on ClinicalTrials.gov