Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02350907
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Bern

Brief Summary:
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.

Condition or disease
Gonorrhoea

Layout table for study information
Study Type : Observational
Actual Enrollment : 261 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens [ Time Frame: Day of specimen sampling ]

Biospecimen Retention:   Samples With DNA
Swabs from the urethra, rectum, oropharynx, vagina and endocervix


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male and females at risk of gonorrhoea infection.
Criteria

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.

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): NCT02350907


Locations
Layout table for location information
Switzerland
University Hospital of Bern
Bern, Switzerland, 3010
Ambulatorium Kanonengasse
Zurich, Switzerland, 8004
Checkpoint Zurich
Zurich, Switzerland, 8005
Sponsors and Collaborators
University of Bern
Investigators
Layout table for investigator information
Principal Investigator: Nicola Low University of Bern, Institute of Social and Preventive Medicine

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02350907     History of Changes
Other Study ID Numbers: 25/2013
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

Keywords provided by University of Bern:
antimicrobial resistance
point-of-care testing
Neisseria gonorrhoeae

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents
Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female