Clinical Utility of Rapid CT/NG Testing in the ED
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|ClinicalTrials.gov Identifier: NCT02200224|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : May 9, 2016
The purpose of this study is to:
- 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).
- 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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Sexually Transmitted Diseases||Other: Rapid Testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Utility of Rapid CT/NG Testing in the ED|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Rapid Testing/Treatment Group
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.
Other: Rapid Testing
No Intervention: Control
All subjects enrolled in the control group will receive CT/NG and TV testing according to the current standard of care for Johns Hopkins ED.
- Overtreatment rate of CT/NG between the control and interventional groups [ Time Frame: 2 week follow-up ]Overtreatment is defined as CT/NG negative patients who received antibiotic treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200224
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Andrea Dugas, MD,PhD||Johns Hopkins University|