Clinical trial NCT04268342: Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)
Official title: Gonorrhoea Resistance Assessment by Nucleic Acid Detection: A Program Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Resistance, Microbial
Antimicrobial Stewardship
Gonorrhea
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Kirby Institute
name: Monash University
name: South Australian Health and Medical Research Institute
name: University of Melbourne
name: University of California, Los Angeles
name: Griffith University
name: Queensland Health
name: St Vincent's Hospital, Sydney
name: SpeeDx Pty Ltd
name: NSW Health Pathology
name: University of Sydney
First posted: 2020-02-13
Enrollment: 1626
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with gonorrhoea infection at the return visit

Exclusion Criteria:

* Patients for whom ciprofloxacin is contraindicated

Primary outcomes:
measure: Change in ceftriaxone use
timeFrame: 12 months after implementation commences
Secondary outcomes:
measure: Cure rate
timeFrame: At 12 months after implementation commences
measure: Acceptability
timeFrame: 1-12 months after implementation commences
measure: Cost effectiveness
timeFrame: 12 months after implementation commences
measure: Process evaluation
timeFrame: 12 months after implementation commences
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: University of Queensland
state: Queensland
Study officials:
affiliation: The University of Queensland
name: David Whiley, PhD
role: PRINCIPAL_INVESTIGATOR
References: