tuberculosis
Conditions
Interventions
patients who developed DIH during initial standard antituberculous therapy
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Confirmed of active tuberculosis 2)Any nationalities 3)Patients who were initially treated with standard 4 drugs regimens for antituberculosis, developed DIH, and stopped of all antitubercuous drugs during intensive phase 4)written informed consent
Exclusion criteria
Exclusion criteria: 1)HIV infection 2)Pregnancy of breast-feeding 3)Liver cirrhosis 4)Acute or chronic hepatitis infection 5)Known resistance against INH or RFP 6)Persistent liver damage 7)Abnormal laboratory finding; WBC <2,000/mm3, Hgb <7g/dL, Platelet count <50,000/mm3 8)Patients whom the attending physician decided unsuitable for entering the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of safe reintroduction of PZA after INH/RFP re-administration for patients who developed DIH during initial standard antituberculous therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Days of onset of DIH after starting initial standard therapy Days of recovery after stopping initial standard therapy Days of recurrence of DIH after readministration | — |
Countries
Japan
Contacts
Public ContactJin TAKASAKI
National Center for Global Health and Medicine Respiratory Medicine
Outcome results
None listed