NCT02386514

Brief Summary

To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

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

January 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

Same day

First QC Date

January 9, 2015

Last Update Submit

January 2, 2017

Conditions

Infection

Keywords

sexually transmitted infectiongonorrheachlamydiapresumptive therapy

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae

    comparative test characteristics to traditional swab in the Emergency Department.

    24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients greater than 18 years of age presenting with a complaint that triggers the providing clinician to obtain a gonorrhea and chlamydia test by the traditional format.

You may qualify if:

  • Clinical concern for gonorrhea and/or chlamydia infection
  • Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay

You may not qualify if:

  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Wilson SP, Vohra T, Goldberg J, Price C, Calo S, Mahan M, Miller J. Reliable Rapid Assay for Gonorrhea and Chlamydia in the Emergency Department. J Emerg Med. 2017 Dec;53(6):890-895. doi: 10.1016/j.jemermed.2017.08.094. Epub 2017 Oct 23.

    PMID: 29074030DERIVED

MeSH Terms

Conditions

InfectionsSexually Transmitted DiseasesGonorrheaChlamydia Infections

Condition Hierarchy (Ancestors)

Communicable DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Physician

Study Record Dates

First Submitted

January 9, 2015

First Posted

March 12, 2015

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

US(1)