Clinical trial NCT06369220: A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chlamydia Trachomatis Infection
Neisseria Gonorrhoeae Infection
Mycoplasma Genitalium Infection
Keywords: Sexually transmitted infections
Urogenital infections
Point of care testing
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Molecular Systems, Inc
First posted: 2024-04-16
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

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)

Primary outcomes:
measure: Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG)
timeFrame: On the day of the medical encounter (Day 1)
Secondary outcomes:
measure: Percentage of Participants Given Inappropriate Treatment for CT Infection
timeFrame: On the day of the medical encounter (Day 1)
measure: Percentage of Participants Given Inappropriate Treatment for NG Infection
timeFrame: On the day of the medical encounter (Day 1)
measure: Percentage of Participants Given Inappropriate Treatment for MG Infection
timeFrame: On the day of the medical encounter (Day 1)
measure: Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire
timeFrame: Once every 2 weeks until end of study (approximately 4 months)
measure: Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire
timeFrame: On the day of the medical encounter (Day 1)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco City Clinic
state: California
city: Hamilton Square
country: United States
facility: Planned Parenthood of Northern, Central, and Southern New Jersey, Inc.
state: New Jersey
city: Perth Amboy
country: United States
facility: Planned Parenthood of Northern, Central and Southern New Jersey
state: New Jersey
city: Killeen
country: United States
facility: Baylor Scott & White Health - Kileen
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Zune Huynh, MD
role: STUDY_DIRECTOR
References: