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 | Completed FDA Device

• 1 other identifier: LIA-STI-542
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Sexually transmitted infections; Urogenital infections; Point of care testing

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)

  An inappropriate treatment is defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by EL-PCR.

  On the day of the medical encounter (Day 1)

Secondary Outcomes (5)

• Percentage of Participants Given Inappropriate Treatment for CT Infection

  On the day of the medical encounter (Day 1)

• Percentage of Participants Given Inappropriate Treatment for NG Infection

  On the day of the medical encounter (Day 1)

• Percentage of Participants Given Inappropriate Treatment for MG Infection

  On the day of the medical encounter (Day 1)

• Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire

  Once every 2 weeks until end of study (approximately 4 months)

• Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire

  On the day of the medical encounter (Day 1)

Study Arms (2)

Standard of Care (SOC) Arm: Standard Practice

OTHER

In the SOC arm, the clinician will evaluate the participant based on standard practice.

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

Point of Care (POC) Arm: cobas® liat CT/NG/MG

EXPERIMENTAL

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.

Diagnostic Test: cobas® liat CT/NG/MG nucleic acid test

Interventions

cobas® liat CT/NG/MG nucleic acid test DIAGNOSTIC_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.

Point of Care (POC) Arm: cobas® liat CT/NG/MG

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

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.

Standard of Care (SOC) Arm: Standard Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sexually active people
• People seeking medical services for symptoms consistent with a sexually transmitted infection (STI) and/or known exposure to an STI

You may not qualify if:

• Previously enrolled in the study
• Unable to provide informed consent
• Currently pregnant
• Declines POC testing
• Presents for routine STI screening (asymptomatic)
• Use of antimicrobial agents active against CT, NG, or MG during the 21 days before sample collection. Example of such antimicrobial agents include the following: Macrolides (e.g., azithromycin and erythromycin); Penicillins (e.g., amoxicillin); Tetracyclines (e.g., doxycycline); Fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin, and moxifloxacin); Cephalosporins (e.g., ceftriaxone and cefixime)
• Use of phenazopyridine-containing urinary pain relief medicines (ie, Azo or Pyridium) within 2 days prior to sample collection
• Contraindication to vaginal swab sampling where vaginal swab sampling is the only option available
• Urination within 1 hour prior to sample collection (for subjects providing urine sample)

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Roche Molecular Systems, Inc: collaborator

Study Sites (4)

San Francisco City Clinic

San Francisco, California, 94103, United States

Location

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

Hamilton Square, New Jersey, 08690, United States

Location

Planned Parenthood of Northern, Central and Southern New Jersey

Perth Amboy, New Jersey, 08861, United States

Location

Baylor Scott & White Health - Kileen

Killeen, Texas, 76543, United States

Location

MeSH Terms

Conditions

Gonorrhea; Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Zune Huynh, MD

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: July 29, 2024
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)