Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea (RaDAR-Go)

July 12, 2019 updated by: University of Bern

Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go

The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital of Bern
      • Zurich, Switzerland, 8004
        • Ambulatorium Kanonengasse
      • Zurich, Switzerland, 8005
        • Checkpoint Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult male and females at risk of gonorrhoea infection.

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or female, aged 18 years or above.
  • Participant is literate in German, French, English or Hungarian.

  • Participant is at risk for a N. gonorrhoeae infection. This is defined as:

    1. exhibiting signs/symptoms of a N. gonorrhoeae infection.
    2. having a sexual partner who has been diagnosed with a N. gonorrhoeae infection.

    3. participating in high-risk activities for a N. gonorrhoeae infection.

      Exclusion Criteria:

  • Subject does not agree to undergo diagnostic test for gonorrhoea.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens
Time Frame: Day of specimen sampling
Day of specimen sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Nicola Low, University of Bern, Institute of Social and Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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