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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04268342




Registration number
NCT04268342
Ethics application status
Date submitted
6/02/2020
Date registered
13/02/2020

Titles & IDs
Public title
Gonorrhoea Resistance Assessment by Nucleic Acid Detection (GRANDII)
Scientific title
Gonorrhoea Resistance Assessment by Nucleic Acid Detection: A Program Evaluation
Secondary ID [1] 0 0
17/180
Universal Trial Number (UTN)
Trial acronym
GRANDII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug Resistance, Microbial 0 0
Antimicrobial Stewardship 0 0
Gonorrhea 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Resistance guided treatment for gonorrhoea infection

No intervention: Standard care - 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.

Active comparator: Implementation - 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 interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in ceftriaxone use
Timepoint [1] 0 0
12 months after implementation commences
Secondary outcome [1] 0 0
Cure rate
Timepoint [1] 0 0
At 12 months after implementation commences
Secondary outcome [2] 0 0
Acceptability
Timepoint [2] 0 0
1-12 months after implementation commences
Secondary outcome [3] 0 0
Cost effectiveness
Timepoint [3] 0 0
12 months after implementation commences
Secondary outcome [4] 0 0
Process evaluation
Timepoint [4] 0 0
12 months after implementation commences

Eligibility
Key inclusion criteria
* Patients diagnosed with gonorrhoea infection at the return visit
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients for whom ciprofloxacin is contraindicated

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2024
Actual
Sample size
Target
1626
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
0733651111 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Kirby Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South Australian Health and Medical Research Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Melbourne
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of California, Los Angeles
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Griffith University
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
Queensland Health
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
St Vincent's Hospital, Sydney
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/industry
Name [9] 0 0
SpeeDx Pty Ltd
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
NSW Health Pathology
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University of Sydney
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Whiley, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is not a plan to make individual participant data available at this stage.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04268342