Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea

Gonorrhoea Clinical Trial

— RaDAR-Go  

Official title:

Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350907
• Other study ID #: 25/2013
• Status: Completed
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2019
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gonorrhea
• Gonorrhoea

Locations

Country	Name	City	State
Switzerland	University Hospital of Bern	Bern
Switzerland	Ambulatorium Kanonengasse	Zurich
Switzerland	Checkpoint Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Donà V, Kasraian S, Lupo A, Guilarte YN, Hauser C, Furrer H, Unemo M, Low N, Endimiani A. Multiplex Real-Time PCR Assay with High-Resolution Melting Analysis for Characterization of Antimicrobial Resistance in Neisseria gonorrhoeae. J Clin Microbiol. 2016 Aug;54(8):2074-81. doi: 10.1128/JCM.03354-15. Epub 2016 May 25. — View Citation

Donà V, Smid JH, Kasraian S, Egli-Gany D, Dost F, Imeri F, Unemo M, Low N, Endimiani A. Mismatch Amplification Mutation Assay-Based Real-Time PCR for Rapid Detection of Neisseria gonorrhoeae and Antimicrobial Resistance Determinants in Clinical Specimens. — View Citation

Fingerhuth SM, Bonhoeffer S, Low N, Althaus CL. Antibiotic-Resistant Neisseria gonorrhoeae Spread Faster with More Treatment, Not More Sexual Partners. PLoS Pathog. 2016 May 19;12(5):e1005611. doi: 10.1371/journal.ppat.1005611. eCollection 2016 May. — View Citation

Low N, Unemo M, Skov Jensen J, Breuer J, Stephenson JM. Molecular diagnostics for gonorrhoea: implications for antimicrobial resistance and the threat of untreatable gonorrhoea. PLoS Med. 2014 Feb 4;11(2):e1001598. doi: 10.1371/journal.pmed.1001598. eCollection 2014 Feb. Review. — View Citation

Low N, Unemo M. Molecular tests for the detection of antimicrobial resistant Neisseria gonorrhoeae: when, where, and how to use? Curr Opin Infect Dis. 2016 Feb;29(1):45-51. doi: 10.1097/QCO.0000000000000230. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens		Day of specimen sampling