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Polymerase chain reaction (PCR) for Sexually Transmitted Diseases

N/A
Waitlist Available
Led By Richard G Wilkerson, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signs or symptoms consistent with sexually transmitted infection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study Summary

This trial will test how well a rapid CT/NG test works in diagnosing and treating STIs in women.

Eligible Conditions
  • Sexually Transmitted Diseases (STDs)
  • Gonorrhea
  • Chlamydia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have signs or symptoms that could indicate a sexually transmitted infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Treated With Antibiotics
Secondary outcome measures
Average Score for Patient Satisfaction With Overall Experience.
Average Score for Patient Satisfaction With Provider Explanation.
Average Score for Patient Satisfaction With Treatment Effectiveness.
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rapid Turnaround TestExperimental Treatment2 Interventions
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Group II: Usual CareActive Control1 Intervention
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
684 Previous Clinical Trials
373,045 Total Patients Enrolled
Richard G Wilkerson, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
2 Previous Clinical Trials
250 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment window for this research endeavor still open?

"This research investigation, which was initially advertised on September 24th 2018 and lastly amended on the 19th of September 2022, is not currently taking in new test subjects. Nevertheless, there are 816 other studies that are actively recruiting volunteers."

Answered by AI

To which individuals does eligibility for this research trial apply?

"This medical trial seeks to enrol 64 participants, between the ages of maturity and retirement, that are presently diagnosed with gonorrhea. To be eligible for this study, female patients must also meet the following requirements: demonstrate typical manifestations of a sexually transmitted disease; have their urine sample collected and pelvic exam administered as part of routine clinical practice; obtain permission from their doctor to treat based on rapid test results; and sign an informed consent form."

Answered by AI

Are adults aged 25 and above eligible for enrollment in this trial?

"The eligibility criteria for this clinical trial only allows for applicants between 18 and 65, leaving out those under the age of consent. However, there are 218 studies that cater to minors and 631 trials specifically designed for seniors."

Answered by AI
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~10 spots leftby Mar 2025