Clinical Utility of Rapid CT/NG Testing in the ED

NCT ID: NCT02200224

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Sexually Transmitted Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rapid Testing

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rapid Testing

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Rich Rothman

Professor, Vice Chair of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Dugas, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30392736 (View on PubMed)

Other Identifiers

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U54EB007958

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHUIRB00026782

Identifier Type: -

Identifier Source: org_study_id

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