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Trial registered on ANZCTR
Registration number
ACTRN12613000599774
Ethics application status
Approved
Date submitted
9/05/2013
Date registered
27/05/2013
Date last updated
12/07/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Short-course Isoniazid and Rifapentine for Cost-effective Latent tuberculosis Eradication
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Scientific title
Randomised controlled trial for cost-benefit of short-course isoniazid and rifapentine versus 9-month course of isoniazid in latent tuberculosis infection
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
U1111-1142-8697
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Trial acronym
SIRCLE (Short-course Isoniazid and Rifapentine for Cost-effective Latent tuberculosis Eradication)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Latent tuberculosis infection
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Condition category
Condition code
Infection
289444
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A 12 dose course of weekly isoniazid (900mg) and rifapentine (900mg) tablets.
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Intervention code [1]
287126
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Treatment: Drugs
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Intervention code [2]
287242
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Prevention
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Comparator / control treatment
A 270 dose course of daily isoniazid tablets (300mg)
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Control group
Active
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Outcomes
Primary outcome [1]
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Cost-benefit of 12 dose isoniazid/rifapentine versus 270 dose isoniazid, in AUD per completed course of preventative therapy. Treatment completion is defined as administration of >90% doses of prescribed medication within 16 weeks for short-course isoniazid and rifapentine (3HR) or 12 months for standard course of isoniazid (9H). Medication doses will be assessed clinically and via pharmacy dispensation records. Costs will be assessed from the perspective of the healthcare system, in AUD.
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Assessment method [1]
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Timepoint [1]
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End of treatment
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Secondary outcome [1]
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Treatment completion rate (defined as administration of >90% doses of prescribed medication within 16 weeks for 3HR or 12 months for 9H). Medication doses will be assessed clinically and via pharmacy dispensation records.
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Assessment method [1]
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Timepoint [1]
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End of treatment
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Secondary outcome [2]
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Patient satisfaction between 9H and 3HR, self-reported using a questionnaire with Likert scales.
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Assessment method [2]
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Timepoint [2]
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End of treatment
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Secondary outcome [3]
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Staff satisfaction between 9H and 3HR, self-reported using a questionnaire with Likert scales.
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Assessment method [3]
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Timepoint [3]
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End of trial
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Eligibility
Key inclusion criteria
Males and non-pregnant, non-breastfeeding females
Weight > 45kg
Willingness to provide signed informed consent.
Sufficient English-language skills for informed consent.
Clinical indication for latent tuberculosis infection (LTBI) treatment. 1) Person with a positive interferon-gamma release assay (IGRA) (defined as >0.35 IU/mL TB antigen-Nil) AND one of the following: close contact to someone with culture confirmed TB or from a high-risk background, current or planned immunosuppressive therapy, or calcification on chest X-ray and no prior history of TB treatment; 2) IGRA converters defined as a documented change from negative to positive within a two-year period; 3) Persons with any other clinical indication for LTBI treatment including persons with a negative IGRA (eg high risk clinical history and pending immunosuppressive therapy)
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Minimum age
18
Years
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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
Confirmed or suspected active TB disease
Contacts to a source case with known resistance to isoniazid and/or rifampicin
Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB.
History of allergy or intolerance to isoniazid or rifamycins
Serum alanine aminotransferase (ALT) > 100 IU/L
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be enrolled via the outpatient clinics of the Victorian Infectious Diseases Service. 80 participants meeting inclusion criteria will be enrolled and randomly allocated to intervention or control group in a non-blinded fashion. Allocation will be performed by a pharmacist not involved in eligibility assessment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be 1:1 and performed according to random sequence computer generated prior to trial enrollment.
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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
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Sample size for this study has been calculated to consider cost differences between the intervention and control groups. Assuming an expected difference of 200$ between cost of the regimens, 36 participants per group will have a power of 80% to detect a difference with a=0.05.
Cost-benefit analysis will be performed, comparing total costs associated with each of 9H vs 3HR in AUD. Costs will be assessed at the level of the healthcare system. Pre-determined costs for each outpatient visits and medication dispensed will be calculated in AUD. As Rifapentine is not currently PBS listed, expected costs will be taken from US commercial prices, in AUD, and sensitivity analysis will also be performed to consider the potential effect of price on overall costs. Any hospitalisation for side effects of therapy will be included, including additional pathology tests and a daily cost of hospitalisation. Daily costs associated with hospitalisation will be taken from National Hospital Cost Data Collection estimates. The relevant Medicare Benefit Schedule fee for any pathology or radiology tests will be applied to tests performed in an outpatient setting.
Descriptive statistical analyses will be presented with regards to treatment adherence, adverse effects and end-of-treatment patient and staff satisfaction. Secondary analyses will be compared to consider differences in event frequency with inter-group comparisons made with chi2 analysis or Fisher’s exact test for categorical variables and the Mann-Whitney test for continuous variables. P-values will be calculated and considered significant if p<0.05. All calculation of probabilities will employ two-tailed tests.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2013
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Actual
6/12/2013
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Date of last participant enrolment
Anticipated
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Actual
25/06/2015
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Date of last data collection
Anticipated
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Actual
11/03/2016
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Sample size
Target
80
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
6874
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3050 - Royal Melbourne Hospital
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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John Burge Estate
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Address [1]
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State Trustees Limited
168 Exhibition Street
Melbourne, VIC 3000
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Melbourne Health
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Address
Royal Melbourne Hospital
Grattan Street
Parkville, VIC 3050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
286011
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Address [1]
286011
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Country [1]
286011
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
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Level 6, Main Building, Royal Melbourne Hospital, Grattan Street, Parkville VIC 3050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
289237
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Approval date [1]
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07/05/2013
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Ethics approval number [1]
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2013.036
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Summary
Brief summary
The aim of this study is to perform a multimodal comparison of 3-month courses of weekly isoniazid and rifapentine (3HR) with 9 months of daily isoniazid (9H) for latent tuberculosis infection, using a variety of indices:
a. Cost-benefit
b. Patient satisfaction
c. Adherence to prescribed therapy
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Trial website
Nil
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Trial related presentations / publications
NA
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Public notes
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Contacts
Principal investigator
Name
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Dr Justin Denholm
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Address
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Victorian Infectious Diseases Service
9N, Main Building, Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
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Country
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Australia
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Phone
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+61 3 9342 7000
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Justin Denholm
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Address
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Victorian Infectious Diseases Service
9N, Main Building, Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
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Country
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Australia
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Phone
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+61 3 9342 7000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Justin Denholm
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Address
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Victorian Infectious Diseases Service
9N, Main Building, Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
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Country
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Australia
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Phone
39928
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+61 3 9342 7000
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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