Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)

NCT04268342 | Unknown

• 1 other identifier: 17/180
• Study Type: interventional
• Target: 1,626
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistance, Microbial; Antimicrobial Stewardship; Gonorrhea

Outcome Measures

Primary Outcomes (1)

• Change in ceftriaxone use

  The proportion of gonorrhoea cases treated at the return visit with ceftriaxone

  12 months after implementation commences

Secondary Outcomes (4)

• Cure rate

  At 12 months after implementation commences

• Acceptability

  1-12 months after implementation commences

• Cost effectiveness

  12 months after implementation commences

• Process evaluation

  12 months after implementation commences

Study Arms (2)

Standard care

NO INTERVENTION

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.

Implementation

ACTIVE COMPARATOR

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.

Other: Resistance guided treatment for gonorrhoea infection

Interventions

Resistance guided treatment for gonorrhoea infection 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

Implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gonorrhoea infection at the return visit

You may not qualify if:

• Patients for whom ciprofloxacin is contraindicated

Sponsors & Collaborators

• The University of Queensland: lead
• Kirby Institute: collaborator
• Monash University: collaborator
• South Australian Health and Medical Research Institute: collaborator
• University of Melbourne: collaborator
• University of California, Los Angeles: collaborator
• Griffith University: collaborator
• Queensland Health: collaborator
• St Vincent's Hospital, Sydney: collaborator
• SpeeDx Pty Ltd: collaborator
• NSW Health Pathology: collaborator
• University of Sydney: collaborator

Study Sites (1)

University of Queensland

Brisbane, Queensland, 0733651111, Australia

Location

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• David Whiley, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 13, 2020
• Study Start: April 26, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: November 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)