None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
TB Unit, Northern Territory Centre for Disease Control
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed