Evaluating Shorter and Safer Tuberculosis Preventive Treatments Comparing Rifampin and Levofloxacin-Based Regimens in Children and Adults with Latent TB Infection

What this Trial Is About

Researchers are evaluating shorter and safer treatment regimens for latent Tuberculosis Infection TB using an adaptive Phase 2 randomized open-label trial design. The study aims to compare the safety, completion, and tolerability of at least three new daily self-administered Tuberculosis Preventive Treatment TPT regimens against the standard 4 months of Rifampin at 10 mgkgday 4R10 in adults and children aged 5 years and older. The goal is to identify regimens lasting two months or less that are not inferior in safety and adherence to the standard treatment, with plans to test the best regimen further in a Phase 3 trial. The trial begins with three treatment groups the standard 4R10 rifampin regimen, 2 months of Rifampin at 20 mgkgday 2R20, and 1 month of daily levofloxacin and rifapentine 1LP. If either experimental regimen fails to meet safety and tolerability criteria, it may be dropped and replaced by another new 1-2 month regimen, such as 1 month of Isoniazid plus rifapentine 1HP. Participants are randomized and monitored closely, with visits scheduled at 2 weeks, during treatment, and after completion. Safety evaluations include clinical assessments, blood tests, and pharmacokinetic sampling. Participants may switch to the standard regimen if intolerability symptoms occur. During the study, participants complete symptom questionnaires, pill counts, and telephone follow-ups to monitor adherence and side effects. After treatment, they are contacted every 3 months for up to 26 months to check for signs of active TB. The primary outcome is the occurrence of severe treatment-related adverse events from the start of treatment until two weeks after completion. Secondary outcomes include treatment completion rates, tolerability, patient preferences, drug exposure, costs, and incidence of active TB. Safety analyses will be regularly conducted to ensure participant well-being throughout the trial.

Shorter and Safer Treatment Regimens for Latent TB