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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)
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Scientific title
Gonorrhoea Resistance Assessment by Nucleic Acid Detection: A Program Evaluation
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Secondary ID [1]
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17/180
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Universal Trial Number (UTN)
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Trial acronym
GRANDII
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Drug Resistance, Microbial
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Antimicrobial Stewardship
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Gonorrhea
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Condition category
Condition code
Infection
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Sexually transmitted infections
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Reproductive Health and Childbirth
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in ceftriaxone use
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Assessment method [1]
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The proportion of gonorrhoea cases treated at the return visit with ceftriaxone
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Timepoint [1]
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12 months after implementation commences
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Secondary outcome [1]
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Cure rate
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Assessment method [1]
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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
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Timepoint [1]
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At 12 months after implementation commences
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Secondary outcome [2]
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Acceptability
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Assessment method [2]
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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.
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Timepoint [2]
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1-12 months after implementation commences
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Secondary outcome [3]
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Cost effectiveness
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Assessment method [3]
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The cost effectiveness of the new management program compared to standard care from the health service perspective
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Timepoint [3]
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12 months after implementation commences
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Secondary outcome [4]
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Process evaluation
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Assessment method [4]
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To document the processes involved in the implementation of the new management program
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Timepoint [4]
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12 months after implementation commences
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Eligibility
Key inclusion criteria
* Patients diagnosed with gonorrhoea infection at the return visit
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients for whom ciprofloxacin is contraindicated
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/07/2024
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Actual
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Sample size
Target
1626
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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0733651111 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Kirby Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash University
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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South Australian Health and Medical Research Institute
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Melbourne
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of California, Los Angeles
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Griffith University
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Address [6]
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Country [6]
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Other collaborator category [7]
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Government body
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Name [7]
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Queensland Health
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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St Vincent's Hospital, Sydney
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Address [8]
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Country [8]
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Other collaborator category [9]
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Commercial sector/industry
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Name [9]
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SpeeDx Pty Ltd
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Address [9]
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Country [9]
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Other collaborator category [10]
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Other
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Name [10]
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NSW Health Pathology
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Address [10]
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Country [10]
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Other collaborator category [11]
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Other
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Name [11]
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University of Sydney
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Address [11]
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Country [11]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04268342
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Whiley, PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
There is not a plan to make individual participant data available at this stage.
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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