A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
Completed · Not applicable
Conditions studied: Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
In brief
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).
Key facts
- Study ID
- NCT06369220
- Run by
- Hoffmann-La Roche
- People needed
- 331
- Starts
- 2024-07-29
- Expected to finish
- 2025-05-28
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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)
Where it is running
- San Francisco City Clinic — San Francisco, California, United States
- Planned Parenthood of Northern, Central, and Southern New Jersey, Inc. — Hamilton Square, New Jersey, United States
- Planned Parenthood of Northern, Central and Southern New Jersey — Perth Amboy, New Jersey, United States
- Baylor Scott & White Health - Kileen — Killeen, Texas, United States
Full record on ClinicalTrials.gov
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