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Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections

NCT03098394 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-31

Study results available
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Summary

The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.

Conditions

  • Sexually Transmitted Infection
  • Gonorrhea Female
  • Chlamydia Females

Interventions

DEVICE

Cepheid Xpert CT/NG Rapid Turnaround Test

This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.

DEVICE

Polymerase chain reaction (PCR)

This is the standard of care for diagnosis of a suspected sexually transmitted infection.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Richard G Wilkerson, MD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2022-03-25
Completion
2023-06-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098394 on ClinicalTrials.gov