Clinical Utility of Rapid CT/NG Testing in the ED
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 9, 2016
May 1, 2016
1.1 years
July 23, 2014
May 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Rapid Testing/Treatment Group
EXPERIMENTALAll 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.
Control
NO INTERVENTIONAll subjects enrolled in the control group will receive CT/NG and TV testing according to the current standard of care for Johns Hopkins ED.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients will be excluded if they are unable to provide informed consent or are not English speaking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
Gaydos CA, Ako MC, Lewis M, Hsieh YH, Rothman RE, Dugas AF. Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management: Report of a Randomized Clinical Trial. Ann Emerg Med. 2019 Jul;74(1):36-44. doi: 10.1016/j.annemergmed.2018.09.012. Epub 2018 Nov 2.
PMID: 30392736DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Dugas, MD,PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Vice Chair of Research
Study Record Dates
First Submitted
July 23, 2014
First Posted
July 25, 2014
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 9, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share