Antimicrobial Stewardship, Drug Resistance, Microbial, Gonorrhea
Conditions
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.
Interventions
OTHERResistance 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
Kirby Institute
Monash University
South Australian Health and Medical Research Institute
University of Melbourne
University of California, Los Angeles
Griffith University
Queensland Health
St Vincent's Hospital, Sydney
SpeeDx Pty Ltd
NSW Health Pathology
University of Sydney
The University of Queensland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A before-after study design will be used to evaluate the proportion of all cases treated with ceftriaxone at return visit within standard care and the new management program respectively. Cure rates within the standard care and the new management program will also be assessed which will help illustrate the impact of the new management program.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with gonorrhoea infection at the return visit
Exclusion criteria
* Patients for whom ciprofloxacin is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ceftriaxone use | 12 months after implementation commences | The proportion of gonorrhoea cases treated at the return visit with ceftriaxone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Process evaluation | 12 months after implementation commences | To document the processes involved in the implementation of the new management program |
Countries
Australia
Outcome results
None listed