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Rapid Diagnostic Assay for Gonorrhea
N/A
Recruiting
Led By Ingrid V. Bassett, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1-6
Awards & highlights
Study Summary
This trial will test two methods of rapid diagnosis for urethritis & cervicitis in a clinic setting. 100 patients will be tested to compare the methods.
Who is the study for?
This trial is for adults over 18 with symptoms of urethritis or cervicitis, who can provide a urine or vaginal swab specimen. It's not for pregnant individuals, those with non-genital symptoms, suspected Monkeypox, known exposure to Gonorrhea/Chlamydia, or under 18.Check my eligibility
What is being tested?
The study compares a rapid 30-minute desktop assay against the standard point-of-care gram stain for diagnosing Gonorrhea and Chlamydia in patients with signs of urethritis/cervicitis at Massachusetts General Hospital Sexual Health Clinic.See study design
What are the potential side effects?
Since this trial tests diagnostic methods rather than treatments, there are no direct side effects from the interventions themselves. However, usual risks associated with providing specimens like discomfort may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 1-6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1-6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antibiotics
Participant Visit Duration
Sample Processing Time
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Rapid STI TestExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Point-of-care gram stain
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,345 Total Patients Enrolled
American Sexually Transmitted Diseases AssociationUNKNOWN
Ingrid V. Bassett, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have symptoms that match urethritis or cervicitis.You have been in close contact with someone who has gonorrhea or chlamydia.You have symptoms in a place other than the genitals at the same time.You have symptoms of a sudden infection in your urethra or cervix.You are suspected or confirmed to have Monkeypox.You have had contact with someone who has gonorrhea or chlamydia.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Rapid STI Test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available for this experiment?
"Confirmed. According to information provided on clinicaltrials.gov, the current recruitment phase for this medical trial began on March 1st 2023 and was last modified March 22nd 2023. The study is seeking a total of 100 patients from one particular site."
Answered by AI
What is the maximum capacity of individuals participating in this medical experiment?
"Affirmative, there is evidence on clinicaltrials.gov that this investigation is seeking to fill participant positions. This research effort was first published on March 1st 2023 and last amended on the 22nd of the same month. The study needs 100 volunteers from a single medical centre."
Answered by AI
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