None listed
Conditions
Brief summary
Traditionally, latent tuberculosis infection (LTBI) in Australia are treated with either six to nine months of daily isoniazid (6-9H). These regimens are hepatotoxic and long. Recent randomized trials have shown that two shorter regimens are equally effective, but substantially less toxic. Four months of daily rifampicin (4RIF) and three months of once weekly rifapentine and isoniazid (3HP). This study will address the following primary research question: What is the treatment completion rate for patients with LTBI treated with home-based 3HP plus SMS monitoring, compared to daily self-administered 4RIF?
Interventions
Combination therapy (‘3HP’) (intervention arm): 3 months of self-monitored once-weekly isoniazid (oral 900 mg) and weekly rifapentine (oral 900mg). Adherence will be monitored through once-weekly SMS or phone call sent by clinic staff. Patients will also attend the clinic at the end of the first month of treatment, to monitor for adverse events.
Sponsors
Royal Prince Alfred Hospital, Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Patients aged greater than or equal to 2 years old. 2. Eligible for treatment for LTBI, by either: a. A TST of 10mm or greater, or b. A positive Interferon Gamma Release Assay (IGRA), or c. A negative TST in the presence of HIV infection in a contact of a person with confirmed tuberculosis infection. 3. Access to EITHER a mobile phone OR landline telephone (people who cannot use phone will be called instead of SMS).
Exclusion criteria
Exclusion criteria: 1. Presumptive tuberculosis in which TB has not been excluded 2. Confirmed tuberculosis. 3. Treatment for active tuberculosis. 4. History of isoniazid and/or rifampicin resistant tuberculosis. 5. Tuberculosis in the source case (i.e. ‘index’ case) known to be resistant to either isoniazid or rifampicin at the time of enrolment. 6. History of hypersensitivity to isoniazid, rifapentine, or rifamycins. 7. Medical conditions requiring the use of medication interacting with study medication 8. Weight of the participant < 10.0 kg 9. Currently pregnant, planning to become pregnant, or breastfeeding. 10. Consideration for solid organ transplantation. 11. Unable to give informed consent 12. AST over 3 times the upper limit of normal. 13. Known porphyria
Outcome results
None listed