NCT02350907

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

3 active sites

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 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

January 20, 2015

Last Update Submit

July 12, 2019

Conditions

Gonorrhoea

Keywords

antimicrobial resistancepoint-of-care testingNeisseria gonorrhoeae

Outcome Measures

Primary Outcomes (1)

  • Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens

    Day of specimen sampling

Eligibility Criteria

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

Adult male and females at risk of gonorrhoea infection.

You may qualify if:

  • 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:
  • exhibiting signs/symptoms of a N. gonorrhoeae infection.
  • having a sexual partner who has been diagnosed with a N. gonorrhoeae infection.
  • participating in high-risk activities for a N. gonorrhoeae infection.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Bern

Bern, 3010, Switzerland

Location

Ambulatorium Kanonengasse

Zurich, 8004, Switzerland

Location

Checkpoint Zurich

Zurich, 8005, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 24503544BACKGROUND

  • 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.

    PMID: 27196299BACKGROUND

  • 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.

    PMID: 27225407BACKGROUND

  • 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.

    PMID: 26658656BACKGROUND

  • 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.

    PMID: 29950339RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Swabs from the urethra, rectum, oropharynx, vagina and endocervix

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Nicola Low

    University of Bern, Institute of Social and Preventive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

CH(3)