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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: Completed NA study of Sexually Transmitted Infections and Urethritis, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
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 |
What the finished NCT05564299 record still lists
NCT05564299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 898-participant average among 10 other Sexually Transmitted Infections trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05564299's enrollment target sits among peer trials
98 10th of 10 higher than 1 of 10 other Sexually Transmitted Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sexually Transmitted Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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