Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment
Status:
Not yet recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
This study is a clinical trial conducted to determine whether the sitafloxacin-containing
three-month regimens are as effective as the standard six-month regimen and the four-month
rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and
moxifloxacin for ethambutol) for treatment of pulmonary tuberculosis. The standard six-month
regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide, followed by four
months of isoniazid and rifampin. The four-month regimen consists of two months of isoniazid,
rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid rifapentine
and moxifloxacin. The new three-month tuberculosis treatment regimens are six weeks of
isoniazid, rifapentine, Sitafloxacin, and pyrazinamide, followed by seven weeks of isoniazid,
rifapentine, and Sitafloxacin, or 13 weeks of isoniazid, rifapentine, Sitafloxacin, and
pyrazinamide. The primary research question is to evaluate the efficacy and safety of the 3
month Sitafloxacin-containing regimen, and to determine if it can shorten the treatment of
drug-susceptible pulmonary tuberculosis while achieving non-inferiority in treatment success
with the current 6 month and 4 month treatment regimens. Safety, side effects of Sitafloxacin
for participants in the clinical trial are also assessed. Rates of cure, treatment success,
recurrence, and cure (cure without recurrence) are determined for subgroup analysis in the
standard six-month regimen group, the four-month regimen group, and two three-month regimen
groups.