Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea | NCT02350907

Studies
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea

NCT02350907

Sponsor

University of Bern

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

261Actual

Phase

Not provided

Conditions

Gonorrhoea

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 20, 2015

First Submission Date that Met QC Criteria

Jan 26, 2015

First Posted Date

Jan 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

261Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult male and females at risk of gonorrhoea infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicola Low	University of Bern, Institute of Social and Preventive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Bern		Bern		3010	Switzerland
Ambulatorium Kanonengasse

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24503544	Background	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.
27196299	Background	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.

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses