Tuberculosis
Conditions
Interventions
New regimen 1:Sitafloxacin-containing Regimen
New regimen 2:Sitafloxacin&SXT-containing Regimen
Contral group 1:WHO regimen
Contral group 2:NEJM four-month regimen
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Age 18 years to 70. (2)At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing. (3)Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin and isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, co-trimoxazole(SXT) and Sitafloxacin. (4)Patients have written informed consent.
Exclusion criteria
Exclusion criteria: (1)HIV-positive individuals. (2)Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals. (3)Women who are currently pregnant or breast-feeding. (4)The patients refused treatment with medications (5)Extra-pulmonary or Disseminated TB. (6)Mycobacterium tuberculosis/nontuberculous mycobacterium co-infection. (7)steroid-dependent and those on steroid treatment. (8)Known allergy to one or more of the study drugs. (9)Patients who have received any investigational drug in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| outcome of treatment;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| AFB in 2rd month;TB disease-free survival at six and twelve months; | — |
Countries
China
Contacts
Public ContactZhang Ying, Xu Kaijin
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innov
Outcome results
None listed