A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections

Roche

Status: Enrolling

Conditions: Neisseria Gonorrhoeae Infection; Chlamydia Trachomatis Infection; Mycoplasma Genitalium Infection

Treatments: Diagnostic Test: cobas® liat CT/NG/MG nucleic acid test; Other: Standard of Care (SOC): Clinician's Standard Practice

Study type: Interventional

Funder types: Industry

Identifiers

NCT06369220

LIA-STI-542

Details and patient eligibility

About

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).

Full description

The study is designed as a block randomized, controlled 2-arm prospective study. The study targets to enroll approximatively 348 participants at increased risk of sexually transmitted infections (STIs)-participants who have known contact with CT/NG/MG (including participants who report knowledge or suspicion of STI exposure, despite the uncertainty of the specific STI pathogen or contact testing results), or participants with symptoms suggestive of STI-to participate in this study. Participants who give consent will provide demographic information and urogenital specimen(s) for CT/NG/MG testing on the cobas® liat system and for external laboratory-polymerase chain reaction (EL-PCR) testing. Participants will be randomized in a 1:1 ratio in blocks (of multiples of 2) stratified by the site to either of the following arms:

• Standard of Care (SOC)
• Point of Care (POC)

In both arms, the clinician will see and evaluate the participant and will complete a standardized form, known as a patient management plan (PMP), at the conclusion of the participant's encounter. The critical difference between the arms is that the clinician in the POC arm will be provided POC test results upon which they may choose to base their clinical decisions, whereas the SOC arm will not receive POC test results.

Enrollment: 348 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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
• Use of any over-the-counter feminine hygiene products (internally or externally), such as vaginal moisturizers, lubricants (e.g., Replens, RepHresh, etc.), and feminine washes/vaginal douches, etc. within the 3 days prior to sample collection. The use of tampons or pads during menses is not an exclusionary criterion.
• 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

Standard of Care (SOC) Arm: Standard Practice

Other group

Description:

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

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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