2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Rationale:
Shorter regimens of high dose daily rifampin may be safe, and as effective as the standard
rifampin regimen when taken for 4 months to treat latent TB (LTBI). However, there is
insufficient evidence on the optimal dose of rifampin that has similar efficacy as the
standard 4-month rifampin regimen without jeopardizing safety or affecting completion rates.
Objectives:
The general purpose of this study is to determine if rifampin at double or triple the
standard dose for 2 months is as safe and effective as the standard dose of rifampin when
taken for 4 months to treat latent tuberculosis (TB).
Treatment:
Persons who need treatment for latent TB, will be given rifampin, either at the standard dose
(10mg/kg/day) for 4 months (control arm); or at double dose (20mg/kg/day) for 2 months
(intervention arm 1); or at triple dose (30mg/kg/day) for 2 months (intervention arm 2).
Design:
This is 1:1:1 randomized, phase 2b, partially blind, controlled trial. The two higher doses
(intervention arms) will be administered double-blind: participants and providers will be
aware of the duration of their regimen, but they will both remain blinded to the specific
dose (i.e. 20 or 30 mg/kg/day) for those randomized to 2-months regimens. All members of the
same household of a patient with newly diagnosed active pulmonary TB will be randomized
together (i.e. cluster randomized).
Population and setting:
Adults and children aged 10 years and above, who have latent TB infection and are recommended
by their doctor to take treatment for latent TB can participate in the study.
The planned number of persons with latent TB to recruit is about 1359 in total (or about 453
for each of the three arms).
The study will take place in 6 sites: four in Canada (Calgary, Edmonton, Montreal and
Vancouver), one in Indonesia (Bandung) and one in Viet Nam (1 clinic in Ho Chi Min City and 3
clinics in Ha Noi).
Outcomes:
Primary outcomes are: 1) Treatment completion and 2) Safety (i.e. grade 3-5 adverse events).
Secondary outcomes are: 1) Safety (i.e. grade 1-2 adverse events) and 2) Efficacy (i.e. rates
of active TB in the 26 months post-randomization). More information on how outcomes are
defined is provided in the detailed description below.
Phase:
Phase 2
Details
Lead Sponsor:
McGill University McGill University Health Centre/Research Institute of the McGill University Health Centre