Efficacy and Safety of Isoniazid, Rifampicin and Moxifloxacin for the Intensive Phase of Initial Therapy of PTB
NCT04187469 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286
Last updated 2019-12-05
Summary
This study aims to find an optimized initial regimen for pulmonary tuberculosis(PTB), evaluating the efficacy, safety and acceptability of isoniazid, rifampicin and moxifloxacin(HRM) for the intensive phase of initial therapy of PTB, compared with the standard initial regimen.
Conditions
- Pulmonary Tuberculosis
Interventions
- DRUG
-
Moxifloxacin, Isoniazid, Rifampicin
Moxifloxacin 400 mg/day, Rifampicin ≤50 kg 450 mg/day \> 50 kg 600 mg/day, Isoniazid 300 mg/day. All treatment is taken daily, for a duration of up to 6 months depending on treatment arm.
- DRUG
-
Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
Rifampicin ≤50 kg 450 mg/day, \>50 kg 600 mg/day, Isoniazid 300 mg/day, Pyrazinamide 1500mg/day, Ethambutol ≤50 kg or the elderly 750mg/day, \>50 kg 1000mg/day. All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm.
Sponsors & Collaborators
-
Fifth Affiliated Hospital, Sun Yat-Sen University
lead OTHER
Principal Investigators
-
Li Ding, M.D · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Yuanli Chen, M.Med · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Xi Liu, M.D · The Fifth Affiliated Hospital, Sun Yat-sen University
-
JinYu Xia, M.Med · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Zhongsi Hong, M.Med · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Jian Liu, M.D · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Minyi Lin, M.Med · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Lisi Deng, M.Med · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Lei Luo · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Yayi Huang · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Xiaoqing Luo · The Fifth Affiliated Hospital, Sun Yat-sen University
-
Yin Li · The Fifth Affiliated Hospital, Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2023-02-01
- Completion
- 2024-02-01
Countries
- China
Study Locations
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