Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Tuberculosis, Pulmonary
Interventions
DRUG

Sitafloxacin

In our Intervention group, sitafloxacin replace the ethambutol, 200mg/d

DRUG

SMZ/TMP

In our The three-month Rifapentine\&Isoniazid\&Pyrazinamide\&Sitafloxacin\&SMZ/TMP-containing regimen, Six weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and Sitafloxacin, followed by seven weeks of daily treatment with rifapentine, isoniazid, ,SMZ/TMP and Sitafloxacin, SMZ 80mg/kg/d, TMP16mg/kg/d

DRUG

Rifampin

Rifampin is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, Rifampin 600mg (8-12mg/kg/d)

DRUG

Pyrazinamide

Pyrazinamide is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 2000mg (20-30mg/kg/d)

DRUG

Rifapentine

In our Intervention group, rifapentine replace rifampin, 600mg/d

DRUG

Isoniazid

Isoniazid is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 300mg (4-6mg/kg/d)

DRUG

Ethambutol

Ethambutol is a first-line antimicrobial agent against drug-susceptible tuberculosis in WHO guideline, 1200mg (15-25mg/kg/d)

DRUG

Moxifloxacin

Moxifloxacin is a fourth-generation fluoroquinolone with potent activity against M. tuberculosis in vitro and in vivo, 400mg (7.5-10mg/kg/d)

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER

NCT05454345 - Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment | Biotech Hunter | Biotech Hunter