N/A
N=98
Rapid Diagnostic Assay for Gonorrhea and Chlamydia
Urethritis · Cervicitis · Sexually Transmitted Infections
Bottom Line
View on ClinicalTrials.gov: NCT05564299 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis — 7; 1 Antibiotic days of therapy (DOT) — p=0.053
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rapid 30-minute Desktop Assay (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis |
7; 1 | 0.053 |
| SECONDARY Participant Visit Duration |
57; 87 | — |
| SECONDARY Sample Processing Time |
— | — |
| SECONDARY Time to Result |
6.5; 34 | — |
| SECONDARY Test-concordant Antibiotic Use for Gonorrhea |
41; 46 | — |
| SECONDARY Diagnosis-concordant Antibiotic Use for Gonorrhea |
43; 48 | — |
| SECONDARY Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results |
4; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05564299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.