Rapid Diagnostic Assay for Gonorrhea and Chlamydia
Status
Conditions
Treatments
Details and patient eligibility
About
This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years of age and older
- Presenting with symptoms of acute urethritis or cervicitis
- Willing to provide urine or additional vaginal swab specimen
Exclusion criteria
- Younger than 18 years old
- Presenting with symptoms not consistent with urethritis or cervicitis
- Unwilling or unable to provide urine or vaginal swab specimen
- Pregnant
- Contact of index patients with Gonorrhea or Chlamydia
- Known exposure to Gonorrhea or Chlamydia
- Reporting concurrent symptoms at a non-genital site
- Suspected or confirmed to have Monkeypox
Trial design
Primary purpose
Allocation
Interventional model
Masking
98 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jana Jarolimova, MD, MPH
Data sourced from clinicaltrials.gov
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