Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

Gonorrhea Clinical Trial

— GRANDII  

Official title:

Gonorrhoea Resistance Assessment by Nucleic Acid Detection: A Program Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04268342
• Other study ID #: 17/180
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: October 2022
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1626
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with gonorrhoea infection at the return visit

Exclusion Criteria:

• Patients for whom ciprofloxacin is contraindicated

Related Conditions & MeSH terms

• Antimicrobial Stewardship
• Drug Resistance, Microbial
• Gonorrhea

Intervention

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

Locations

Country	Name	City	State
Australia	University of Queensland	Brisbane	Queensland

Sponsors (12)

Lead Sponsor	Collaborator
The University of Queensland	Griffith University, Kirby Institute, Monash University, NSW Health Pathology, Queensland Health, South Australian Health and Medical Research Institute, SpeeDx Pty. Ltd., St Vincent's Hospital, Sydney, University of California, Los Angeles, University of Melbourne, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ceftriaxone use	The proportion of gonorrhoea cases treated at the return visit with ceftriaxone	12 months after implementation commences
Secondary	Cure rate	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	At 12 months after implementation commences
Secondary	Acceptability	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.	1-12 months after implementation commences
Secondary	Cost effectiveness	The cost effectiveness of the new management program compared to standard care from the health service perspective	12 months after implementation commences
Secondary	Process evaluation	To document the processes involved in the implementation of the new management program	12 months after implementation commences