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

Description

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

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Study Overview

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Study Details

Study overview

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).

A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice

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

Condition
Chlamydia Trachomatis Infection
Intervention / Treatment

-

Contacts and Locations

San Francisco

San Francisco City Clinic, San Francisco, California, United States, 94103

Hamilton Square

Planned Parenthood of Northern, Central, and Southern New Jersey, Inc., Hamilton Square, New Jersey, United States, 08690

Perth Amboy

Planned Parenthood of Northern, Central and Southern New Jersey, Perth Amboy, New Jersey, United States, 08861

Killeen

Baylor Scott & White Health - Kileen, Killeen, Texas, United States, 76543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Zune Huynh, MD, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2025-03-01