Chlamydia Trachomatis Infection Clinical Trial
Official title:
A Study of the Clinical Utility of Point of Care Cobas® Liat CT/NG/MG Nucleic Acid Test Versus Current Standard Practice
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).
Status | Not yet recruiting |
Enrollment | 348 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hoffmann-La Roche | Roche Molecular Systems, Inc |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) | An inappropriate treatment is defined as under and/or overtreatment on the day of the medical encounter based on CDC recommendations for the pathogen-specific results obtained by EL-PCR. | On the day of the medical encounter (Day 1) | |
Secondary | Percentage of Participants Given Inappropriate Treatment for CT Infection | On the day of the medical encounter (Day 1) | ||
Secondary | Percentage of Participants Given Inappropriate Treatment for NG Infection | On the day of the medical encounter (Day 1) | ||
Secondary | Percentage of Participants Given Inappropriate Treatment for MG Infection | On the day of the medical encounter (Day 1) | ||
Secondary | Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire | Healthcare professionals will rate their confidence in and their satisfaction with the POC test and SOC procedures on a 5-point scale from very confident to very unconfident and on a 5-point scale from very satisfied to very dissatisfied, respectively, in response to the Clinician Satisfaction with Diagnostic Test Questionnaire (CSDT-Q). | Once every 2 weeks until end of study (approximately 4 months) | |
Secondary | Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire | Participants will rate their satisfaction with the POC test and SOC procedures on a 5-point scale from very satisfied to very dissatisfied in response to the Patient Satisfaction with Diagnostic Test Questionnaire (PSDT-Q). | On the day of the medical encounter (Day 1) |
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