NCT03098394

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.

Conditions

• Sexually Transmitted Infection
• Gonorrhea Female
• Chlamydia Females

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-24
• Primary completion: 2022-03-25
• Completion: 2023-06-20
• First posted: 2017-03-31
• Last updated: 2023-08-31
• Results posted: 2023-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study