Condition: Tuberculosis Infection, Latent · Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Our study rationale is based on: 1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe; 2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs; 3. 4 months of Rifampin 10mg/kg (4R10) is the safest regimen, but is completed by \<80% of patients; 4. The safety of 2 months of Rifampin 20mg/kg (2R20) is similar to that of 4 months of Rifampin 10mg/kg (4R10), but completion is a concern; 5. 1-month regimens have promising efficacy; 6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg/kg (4R10), and head-to-head with each other. OBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial. Specific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg/kg/day for 4 months (4R10); Experimental: 1) Rifampin at 20 mg/kg/day for 2 months (2R20); (2) one month Levofloxacin and Rifapent…
This description comes directly from the study's public registry record.
Dick Menzies, MD · 514-934-1934 · dick.menzies@mcgill.ca
Chantal Valiquette · 514-934-1934 · chantal.valiquette@affiliate.mcgill.ca
Always discuss trial participation with your own doctor first.
| Centre National Hospitalier Universitaire de Pneumo Phtisiologie de Cotonou (CNHU-PPC) | Cotonou, Benin | Not Yet Recruiting |
| Manaus | Manaus, Brazil | Recruiting |
| Unviversity of Calgary | Calgary, Alberta, Canada | Recruiting |
| The Governors of the University of Alberta | Edmonton, Alberta, Canada | Recruiting |
| BCCDC TB clinic | Vancouver, British Columbia, Canada | Recruiting |
| University of Manitoba | Winnipeg, Manitoba, Canada | Recruiting |
| University of Ottawa | Ottawa, Ontario, Canada | Recruiting |
| St. Michael's Hospital | Toronto, Ontario, Canada | Recruiting |
| University Health Network | Toronto, Ontario, Canada | Recruiting |
| MUHC | Montreal, Quebec, Canada | Recruiting |
| Hopital du Sacré-Coeur de Montreal | Montreal, Quebec, Canada | Recruiting |
| Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB research clinic) | Bandung, Indonesia | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06498414