Study 31 / A5349
Four-Month Rifapentine-Based Regimen for Drug-Susceptible TB
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 2,516 patients with drug-susceptible pulmonary tuberculosis, a 4-month regimen of high-dose rifapentine plus moxifloxacin was non-inferior to the standard 6-month regimen for TB-free survival.
N
2.516
Design
Open-label non-inferiority RCT
Endpunkt
Relapse-free cure at 12 months
Relevanz
2
ErgebnisTB-free survival ~84 % vs ~85 % — non-inferior.
Dorman SE, et al. N Engl J Med. 2021;384(18):1705-1718. 10.1056/NEJMoa2033400
Diskussion & Kritik
First WHO- and CDC-endorsed 4-month regimen for drug-susceptible pulmonary TB in patients ≥12 years — a major step from 6 to 4 months.