Pulmonary Tuberculosis
Conditions
Keywords
pulmonary tuberculosis, isoniazid, arylamine N-acetyltransferase 2, pharmacogenomics, genetic polymorphisms, individualized medicine, drug-induced hepatotoxity
Brief summary
The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.
Interventions
DRUGIsoniazid
Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively
DRUGisoniazed
Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
Sponsors
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed pulmonary tuberculosis patients * Informed consent including pharmacogenomic analysis
Exclusion criteria
* Abnormal liver and kidney function test before treatment * Long-term use of steroids and/or immunodepressants * Inadequate clinical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism | — | 1\) the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week |
Secondary
| Measure | Time frame |
|---|---|
| Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy | — |
Countries
Japan
Outcome results
None listed