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NCT05564299 · ClinicalTrials.gov registry record · NA
Rapid Diagnostic Assay for Gonorrhea and Chlamydia
A NA study of Sexually Transmitted Infections and Urethritis, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT05564299 is a NA study of Sexually Transmitted Infections and Urethritis that has completed, run by Massachusetts General Hospital. The registered enrollment target is 98 participants, below the 898-participant average among 10 other Sexually Transmitted Infections trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05564299, a NA study of Sexually Transmitted Infections and Urethritis, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Rapid 30-minute Desktop Assay
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2024-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05564299
The ClinicalTrials.gov registry entry for NCT05564299 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 10 other Sexually Transmitted Infections trials with a reported enrollment target (89% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sexually Transmitted Infections appearing as the primary indexed condition, and to 1 intervention - of which Rapid 30-minute Desktop Assay is the first listed.
NCT05564299 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05564299 about?
NCT05564299 is a clinical study titled "Rapid Diagnostic Assay for Gonorrhea and Chlamydia". 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 Hosp...
What is the current status of trial NCT05564299?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2023-03-22. Estimated completion is 2024-06-30.
What conditions does trial NCT05564299 study?
This clinical trial studies the following conditions: Sexually Transmitted Infections, Urethritis, Cervicitis.
What interventions are being tested in trial NCT05564299?
The interventions under investigation include: Rapid 30-minute Desktop Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05564299?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564299 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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