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Trial record 13 of 1928 for:    Sexually Transmitted Diseases | NIH

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
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Rich Rothman, 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.


Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Other: Rapid Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Andrea Dugas, MD,PhD Johns Hopkins University

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Responsible Party: Rich Rothman, Professor, Vice Chair of Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02200224     History of Changes
Other Study ID Numbers: JHUIRB00026782
U54EB007958 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female