Clinical Utility of Rapid CT/NG Testing in the ED

Sexually Transmitted Diseases Clinical Trial

Official title:

Clinical Utility of Rapid CT/NG Testing in the ED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200224
• Other study ID #: JHUIRB00026782
• Secondary ID: U54EB007958
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: May 6, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

Other:
• Rapid Testing

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overtreatment rate of CT/NG between the control and interventional groups	Overtreatment is defined as CT/NG negative patients who received antibiotic treatment.	2 week follow-up	No