tuberculosis
Conditions
Interventions
Group A:Once-Weekly chinese Rifapentine(900mg-1200mg)
Group B:Once-Weekly Rifapentine imported (900mg-1200mg)
Group C:Twice-Weekly chinese Rifapentine (450mg-600mg)
Sponsors
Shanghai Public Health Clinical Center, China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 Years to 65 Years male and female; 2. Smear positive and the GeneXpert MTB/RIF (Xpert) assay positive and Rif susceptible; 3. Provision of informed consent for the study; 4. Willingness to be sampled in an out-patient clinic or be admitted to Shanghai Public Health Clinical Center.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding; 2. Known intolerance or allergy to any of the study drugs; 3. Severe hepatic damage or serious complications of other systems; 4. Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, or HIV antiretroviral (ARV) therapy, which have unacceptable interactions with rifamycins; 5. Central nervous system TB.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentrations of rifapentinethe during initial 8 weeks of treatment;Incidence of rifapentine-related adverse events duringthe initial 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants that are sputum culture (in LJ) negative or sputum smear negative for TB at 8 weeks, 20 weeks and 24 weeks;The Early Bactericidal Activity (EBA) expressed as the fall of colony forming units per mL of sputum per day at the intervals: Baseline to Day 3, Baseline to Day 6, Baseline to Day 10,Day 3 to Day 10; | — |
Countries
China
Contacts
Public ContactLu Shuihua
Shanghai Public Health Clinical Center
Outcome results
None listed