Clinical Utility of Rapid CT/NG Testing in the ED

Not Applicable

Completed

• Conditions: Sexually Transmitted Diseases
• Interventions: Other: Rapid Testing

• Registration Number: NCT02200224
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to:

1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the Emergency Department (ED) for a Sexually Transmitted Infection (STI).

2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic under and over treatment for TV in women evaluated in the ED for an STI

3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually Transmitted Infection diagnosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2015-04
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-06
• Last Update Posted: 2016-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• The study population includes women between the age of 18 and 50 who present to the ED and are going to receive CT/NG testing in the ED.

Exclusion Criteria

• Patients will be excluded if they are unable to provide informed consent or are not English speaking.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Testing/Treatment Group	Rapid Testing	All subjects enrolled in the rapid testing group will receive rapid CT/NG and TV testing in addition to the CT/NG Nucleic Acid Amplification Test (NAAT) and wet mount testing that is currently used in the ED.

Primary Outcome Measures

Name	Time	Method
Overtreatment rate of CT/NG between the control and interventional groups	2 week follow-up	Overtreatment is defined as CT/NG negative patients who received antibiotic treatment.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States