pulmonary tuberculosis
Conditions
Interventions
Continue intensive antituberculous therapy until culture conversion up to 16 weeeks, followed by INH/RFP for total 9 months
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of followings 1)Active, smear-positive pulmonary tuberculossis 2)Treated for 8 weeks of initial intensive phase without any untolerable harmful events 3)Smear positive for consecutive 3 times at 6th - 8th weeks of intensive phase, at least one of which was 2+ or 3+ 4)Culture positive at least 2 times on 4th – 8th weeks 5)Written informed concent
Exclusion criteria
Exclusion criteria: 1)HIV positive 2)Systemic corticosteroids or other imunosuppressants administration 3)Pregnancy or breast feeding 4)Resistance of INH and/or RFP 5)Hyperuricemia or past history of gout 6)Any laboratory abnormal finding as follows; T-bil >= 3.0 mg/dL, WBC < 2,000 /mm3, Hgb < 7.0 g/dL, or Plt < 50,000 /mm3 7)Others judjed to be unsuitable as subjects by the physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days to culture conversion (ITT analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)days to culture convertion (PPS analysis) 2)incidence of adversed reaction 3)rate of treatment interuption 4)rate of culture conversion at 9 months | — |
Countries
Japan
Contacts
Public ContactJin Takasaki
National Center for Global Health and Medicine Department of Respiratory Medicine
Outcome results
None listed