Clinical trial NCT02350907: Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea
Official title: Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonorrhoea
Keywords: antimicrobial resistance
point-of-care testing
Neisseria gonorrhoeae
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and females at risk of gonorrhoea infection.

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.


Eligibility 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.

Primary outcomes:
measure: Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens
timeFrame: Day of specimen sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Bern
city: Zurich
country: Switzerland
facility: Ambulatorium Kanonengasse
city: Zurich
country: Switzerland
facility: Checkpoint Zurich
Study officials:
affiliation: University of Bern, Institute of Social and Preventive Medicine
name: Nicola Low
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Dona 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.
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.
citation: Dona 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. J Clin Microbiol. 2018 Aug 27;56(9):e00365-18. doi: 10.1128/JCM.00365-18. Print 2018 Sep.