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Trial registered on ANZCTR


Registration number
ACTRN12619001704189p
Ethics application status
Submitted, not yet approved
Date submitted
22/11/2019
Date registered
4/12/2019
Date last updated
25/02/2020
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing shorter treatment for latent tuberculosis in the Northern Territory
Scientific title
Shorter regimens for treatment of latent tuberculosis in the Northern Territory: a
pragmatic effectiveness study
Secondary ID [1] 299883 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 315299 0
Latent tuberculosis infection 315300 0
Condition category
Condition code
Infection 313600 313600 0 0
Studies of infection and infectious agents
Respiratory 313601 313601 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention therapy will be self-administered combination therapy for treatment of latent tuberculosis infection, consisting of 3 months of weekly oral isoniazid 900mg and weekly oral rifapentine 900mg (3HP). Patients will receive a medication tracker form to record doses and will receive weekly text message reminders. Aherance will be monitred by clinic staff at monthly clinic appointments through review of medication tracker and pill count.

The comparator group will be those receiving the current standard of care (9 months daily isoniazid). Following a baseline period of approximately 6 months of data collection under the current standard of care, the intervention therapy will be implemented and offerred to all eligible patients who are recommended to receive treatment for latent TB infection.
Intervention code [1] 316150 0
Treatment: Drugs
Comparator / control treatment
Current standard of care: self-administered therapy for treatment of latent tuberculosis infection, consisting of 9 months of oral daily or thrice weekly isoniazid (9H), weight adjusted dose up to 300mg or 900mg maximum dose for daily or thrice weekly regimens respecitvely.
Control group
Active

Outcomes
Primary outcome [1] 322050 0
Treatment completion rate. Treatment completion will be assessed by clinic staff through review of patient medication tracker and pill count.

For 3HP, treatment completion is defined as at least 12 valid doses (more than 72 hours apart) of rifapentine and isoniazid within 16 weeks.

For 9H, treatment completion is defined as 270 daily doses or 117 thrice weekly doses, taken within 12 months.
Timepoint [1] 322050 0
End of treatment
Secondary outcome [1] 377147 0
Qualitative assessment of patient satisfaction with latent tuberculosis treatment. Patient satisfaction will be assessed through the use of semi-structured interview including visual analogue scales and qualitative assessment of open ended questions around satisfaction with treatment.
Timepoint [1] 377147 0
End of treatment
Secondary outcome [2] 377148 0
Qualitative assessment of treatment provider satisfaction with latent tuberculosis regimens. Provider satisfaction will be assessed using an web-based survey including visual analogue scales and qualitative assessment of open ended questions.
Timepoint [2] 377148 0
End of trial
Secondary outcome [3] 377149 0
Cost-effectiveness of 3HP versus 9H for treatment of latent tuberculosis infection from the healthcare perspective. Hospital medical records will be used to gather data on the resource use and cost associated with both regimens. This will be assessed for each treatment regimen as cost in AUD per patient completing therapy.
Timepoint [3] 377149 0
End of trial

Eligibility
Key inclusion criteria
Patients with latent tuberculosis infection diagnosed by positive tuberculin skin test (TST) or Interferon-Gamma Release Assay (IGRA), in whom active TB disease has been excluded, and there is a clinical indication for treatment of latent tuberculosis infection.
Minimum age
2 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children less than two years of age or body weight less than 10kg

Anyone with presumed or confired TB disease or is undergoing treatment for TB disease

Those with presumed infection with isoniazid or rifampicin resistant Mycobacterium tuberculosis

Pregnant women or women who expect to become pregnant during the twelve week course of treatment

Those taking any medication which may result in a clinically significant interaction with isoniazid or rifapentine, including people with HIV infection taking antiretroviral medications which may interact with rifapentine such as protease inhibitors or nevirapine.

Those with a history of allergic reaction or hypersensitivity to isoniazid, rifapentine or rifamycins

Those with a AST level that is three or more times higher than the upper limit of normal

Anyone under consideration for solid organ transplantation

Anyone with a history of porphyria

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 design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 304340 0
Other Collaborative groups
Name [1] 304340 0
HOT NORTH
Address [1] 304340 0
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drive Casuarina NT 0810 Australia
Country [1] 304340 0
Australia
Primary sponsor type
Government body
Name
TB Unit, Northern Territory Centre for Disease Control
Address
Royal Darwin Hospital
Royal Darwin Hospital Campus
Rocklands Drive Casuarina NT 0810 Australia
Country
Australia
Secondary sponsor category [1] 304591 0
None
Name [1] 304591 0
Address [1] 304591 0
Country [1] 304591 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304792 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 304792 0
Menzies School of Health Research
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drive Casuarina NT 0810 Australia
Ethics committee country [1] 304792 0
Australia
Date submitted for ethics approval [1] 304792 0
13/11/2019
Approval date [1] 304792 0
19/02/2020
Ethics approval number [1] 304792 0
2019-3595

Summary
Brief summary
In the Northern Territory, nine-months of daily isoniazid is currently recommended for the
treatment of Latent Tuberculosis Infection (LTBI), but less than 50% of those offered
treatment complete it.

A three-month LTBI treatment regimen consisting of 12 weekly doses of two drugs
(isoniazid (H) & rifapentine (P), known as ‘3HP’) is safe and effective. This regimen shows
promise for improving completion of LTBI treatment but is yet to be taken up in Australia.

Darwin TB Clinic will implement 3HP for treatment of LTBI among patients in the greater
Darwin area. We will evaluate the implementation of 3HP by measuring treatment
completion, adverse events, cost-effectiveness, and patient and provider acceptance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98218 0
Dr Chris Lowbridge
Address 98218 0
John Mathews Building (Building 58)
Royal Darwin Hospital Campus
Rocklands Drive, Casuarina NT 0810
Country 98218 0
Australia
Phone 98218 0
+61 08 8946 8411
Fax 98218 0
Email 98218 0
christopher.lowbridge@menzies.edu.au
Contact person for public queries
Name 98219 0
Dr Chris Lowbridge
Address 98219 0
John Mathews Building (Building 58)
Royal Darwin Hospital Campus
Rocklands Drive, Casuarina NT 0810
Country 98219 0
Australia
Phone 98219 0
+61 08 8946 8411
Fax 98219 0
Email 98219 0
christopher.lowbridge@menzies.edu.au
Contact person for scientific queries
Name 98220 0
Dr Chris Lowbridge
Address 98220 0
John Mathews Building (Building 58)
Royal Darwin Hospital Campus
Rocklands Drive, Casuarina NT 0810
Country 98220 0
Australia
Phone 98220 0
+61 08 8946 8411
Fax 98220 0
Email 98220 0
christopher.lowbridge@menzies.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There may be a risk of patient identification if IPD is shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results