Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

Not Applicable

Active, not recruiting

• Conditions: Gonorrhea; Drug Resistance, Microbial; Antimicrobial Stewardship
• Interventions: Other: Resistance guided treatment for gonorrhoea infection

• Registration Number: NCT04268342
• Lead Sponsor: The University of Queensland

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.

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Start: 2022-04-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-28
• Primary Completion: 2023-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1626

Inclusion Criteria

• Patients diagnosed with gonorrhoea infection at the return visit

Exclusion Criteria

• Patients for whom ciprofloxacin is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Implementation	Resistance guided treatment for gonorrhoea infection	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.

Primary Outcome Measures

Name	Time	Method
Change in ceftriaxone use	12 months after implementation commences	The proportion of gonorrhoea cases treated at the return visit with ceftriaxone

Secondary Outcome Measures

Name	Time	Method
Acceptability	1-12 months after implementation commences	The acceptability of the new management program to clinic and laboratory staff and stakeholders will be assessed through a qualitative research study design. Service staff and external stakeholders will be selected purposively to take part in semi-structured in-depth interviews at different stages of the study. Sampling will be informed by data saturation. All interviews will be audio-recorded and transcribed verbatim. Qualitative data will be analysed using a system of thematic 'open' and 'axial' coding. Findings will be descriptive.
Cost effectiveness	12 months after implementation commences	The cost effectiveness of the new management program compared to standard care from the health service perspective
Cure rate	At 12 months after implementation commences	The proportion of gonorrhoea cases treated at the return visit with a negative test of cure within 2-4 weeks within the new management program versus standard care
Process evaluation	12 months after implementation commences	To document the processes involved in the implementation of the new management program

Trial Locations

Locations (1)

University of Queensland; 🇦🇺 Brisbane, Queensland, Australia