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

Infectious Diseases
Neisseria Gonorrhoeae Infection
Chlamydia Trachomatis Infection
Mycoplasma Genitalium Infection

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase N/A

Study Identifier NCT06369220, LIA-STI-542, RD006616

Condition Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection

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

Study 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).

Eligibility Criteria

Gender

All

Age

≥18 Years

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)

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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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

For the latest version of this information please go to www.forpatients.roche.com