Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

NCT ID: NCT04268342

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1626 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-26
• Study Completion Date: 2024-07-30

Brief 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.

Detailed Description

This study aims to demonstrate the feasibility of a new approach to antibiotic stewardship based on individually tailored antibiotic prescribing. Three sexual health clinical services in New South Wales Australia with high caseloads of gay and bisexual men will adopt a new management practice for gonorrhoea infection involving provision of tailored antibiotic therapy by clinicians at the time of gonorrhoea diagnosis and treatment, guided by the results of resistance testing. 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. This differs from existing practice where the prolonged turn-around times for drug resistance testing results mean clinicians must prescribe drug therapy without knowing these results. This can lead to increasing levels of drug resistance to ceftriaxone.

The drug resistance test used in the new program detects genetic material (nucleic acids). It was developed and validated in Australia and is as accurate as existing culture-based drug resistance testing but provides quicker results. Patients treated presumptively at their first clinic visit will be treated with standard of care ceftriaxone. However, for cases treated at the return visit, clinicians will identify gonorrhoea infection that is ciprofloxacin susceptible so that it can be treated with ciprofloxacin therapy, rather than ceftriaxone. This will preserve ceftriaxone for situations where it must be used as the only effective drug available. Established patient follow-up procedures at clinical services will confirm that treatment has been successful.

Quantitative data from the clinical and laboratory services in the study will be used to assess the proportion of all cases treated with ceftriaxone. The cure rate in gonorrhoea cases within the new management program versus standard care will also be assessed which will help illustrate the impact of the new management program.

Conditions

Drug Resistance, Microbial; Antimicrobial Stewardship; Gonorrhea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

When clinical services are in the standard case phase of the study, all cases of gonorrhoea infection diagnosed at those services will be managed according to current standard of care management guidelines i.e. all cases of gonorrhoea infection will be treated with ceftriaxone by injection plus oral azithromycin tablets as first line therapy, regardless of whether the treatment is given at the initial clinic or the return clinic visit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Implementation

When clinical services are assigned to the implementation phase, first line treatment for gonorrhoea infection for patients treated at their first clinic visit will remain the same as it is currently: ceftriaxone by injection plus oral azithromycin tablets. However, patients who are not treated presumptively will be treated at their return visit on the basis of the drug resistance test results. Patients with gonorrhoea infection that is shown to be susceptible to ciprofloxacin will be treated with oral ciprofloxacin therapy when they return for review at clinical services in the implementation phase. Patients with gonorrhoea infection that is not susceptible to ciprofloxacin or with an indeterminate ciprofloxacin result will be treated with ceftriaxone by injection.

Group Type: ACTIVE_COMPARATOR

Resistance guided treatment for gonorrhoea infection

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with gonorrhoea infection at the return visit

Exclusion Criteria

• Patients for whom ciprofloxacin is contraindicated

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Institute

OTHER_GOV

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

South Australian Health and Medical Research Institute

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Griffith University

OTHER

Sponsor Role: collaborator

Queensland Health

OTHER_GOV

Sponsor Role: collaborator

St Vincent's Hospital, Sydney

OTHER

Sponsor Role: collaborator

SpeeDx Pty Ltd

INDUSTRY

Sponsor Role: collaborator

NSW Health Pathology

UNKNOWN

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Whiley, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

University of Queensland

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

17/180

Identifier Type: -

Identifier Source: org_study_id