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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

CompletedNA

Sponsor: Hoffmann-La Roche

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

Interventions: cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (4)

San Francisco, California, United States
Hamilton Square, New Jersey, United States
Perth Amboy, New Jersey, United States
Killeen, Texas, United States