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Sitafloxacin-Containing Regimens for Shortening Tuberculosis Treatment
NCT05454345Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2022
- Primary completion
- Jun 2025
- Sponsor
- First Affiliated Hospital, Zhejiang University School of Medicine
- Modality
- Small Molecules
- Drugs
- sitafloxacin
- Conditions
- pulmonary tuberculosis (TB)
01
Overview
Phase 3, randomised, open-label trial of sitafloxacin in pulmonary tuberculosis (TB) (4 arms), sponsored by First Affiliated Hospital, Zhejiang University School of Medicine. Primary endpoints: TB Disease-free Survival after the completion of the treatment cycle at 26 weeks and Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment at 26 weeks. Planned start Oct 2022; status: not yet recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
3-month Sitafloxacin
13 weeks: Rifapentine, Isoniazid, Pyrazinamide, Sitafloxacin
3-month Sitafloxacin + SMZ/TMP
6 weeks: Rifapentine, Isoniazid, Pyrazinamide, Sitafloxacin -> 7 weeks: Rifapentine, Isoniazid, SMZ/TMP, Sitafloxacin
6-month Standard
8 weeks: Rifampin, Isoniazid, Pyrazinamide, Ethambutol -> 18 weeks: Rifampin, Isoniazid
4-month Moxifloxacin
8 weeks: Rifapentine, Isoniazid, Pyrazinamide, Moxifloxacin -> 9 weeks: Rifapentine, Isoniazid, Moxifloxacin
03
Who it enrols
Adult patients (18-70 years) with confirmed drug-susceptible pulmonary tuberculosis (smear or culture positive). Excludes HIV, extra-pulmonary TB, diabetes, cancer, autoimmune diseases, and severe hepatic/renal dysfunction.
04
Endpoints
Primary
TB Disease-free Survival after the completion of the treatment cycle
Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment
Secondary
The rates of negative sputum conversion
TB disease-free survival at six and twelve months after study treatment assignment
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