Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

NCT04268342 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1626

Last updated 2022-11-28

No results posted yet for this study

Summary

Three sexual health clinical services across Australia and their associated pathology testing laboratories are implementing a new management program for gonorrhoea infection. The services are implementing the use of gonorrhoea drug resistance testing as part of routine clinical and laboratory practice, where drug resistance test results are provided to clinicians quickly to guide choice of antibiotic therapy. Clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone.

Conditions

  • Drug Resistance, Microbial
  • Antimicrobial Stewardship
  • Gonorrhea

Interventions

OTHER

Resistance guided treatment for gonorrhoea infection

For cases of gonorrhoea infection treated at the return visit, a nucleic acid assay will be used to determine individual eligibility for ciprofloxacin treatment

Sponsors & Collaborators

  • Kirby Institute

    collaborator OTHER_GOV
  • Monash University

    collaborator OTHER
  • South Australian Health and Medical Research Institute

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • University of California, Los Angeles

    collaborator OTHER
  • Griffith University

    collaborator OTHER
  • Queensland Health

    collaborator OTHER_GOV
  • St Vincent's Hospital, Sydney

    collaborator OTHER
  • SpeeDx Pty Ltd

    collaborator INDUSTRY
  • NSW Health Pathology

    collaborator UNKNOWN
  • University of Sydney

    collaborator OTHER
  • The University of Queensland

    lead OTHER

Principal Investigators

  • David Whiley, PhD · The University of Queensland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2023-07-30
Completion
2024-07-30

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268342 on ClinicalTrials.gov