UMEM Research Studies

CEPHEID

Sponsor: Cepheid | Status: Recruiting

Start Date: 09/01/2018 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)

Description:

Title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting with Possible Sexually Transmitted Infections (CEPHEID)

Primary Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM

Research Team: 

Dana Beach (dbeach3@som.umaryland.edu)

Kyra Lasko (kyra.lasko@som.umaryland.edu)

Youssef Annous (yannous@som.umaryland.edu)

Objectives: To assess whether an FDA-approved rapid turnaround test (RTAT) for Neisseria gonorrheae and Chlamydia trachomatis infections will lead to more appropriate antibiotic prescription in the emergency department. 

Study design: A prospective, non-blinded, randomized controlled trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center. A total of 96 Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. The subjects will be randomly assigned to either the control group or the experimental group. Study subjects in the control group will be tested for GC/CT only via standard PCR test whereas study subjects in the experimental group will be tested using both rapid TAT and standard PCR tests.

Primary Endpoint: To evaluate the effect of utilizing a rapid turnaround GC/CT test on treatment of patients with possible STIs

Secondary Endpoints:

1- To evaluate the effect of utilizing a rapid turnaround GC/CT test on length of stay in the Emergency Department

2- To compare the congruence of test results between the rapid turnaround GC/CT test with the usual care test (send out PCR) in those subjects that have both performed (Experimental Group).

3- To evaluate the effect of utilizing a rapid PCR test on healthcare costs.

4- To evaluate patient satisfaction with the 2 diagnostic groups.

5- To compare the need for additional healthcare utilization between the groups.

Keywords: Sexually Transmitted Disease, Sexually Transmitted Infection, STD, Gonorrhea, Chlamydia, Rapid Turnaround Test, Vaginal Discharge