AT 2 genotype guided INH dosage for tuberculosis treatment to reduce drug induced liver injury (DILI) in slow acetylator patients
- Conditions
- This study aimed to evaluated the adjusted dose INH can reduce incidence of AT-DILI in SA patients in Thai populationsNAT 2 gene, Isoniazid, Tuberculosis, AT-DILI, Randomized control trial
- Registration Number
- TCTR20210801005
- Lead Sponsor
- Department of medical services, Ministry of Public Health of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
1. Age more than 18 years
2. Newly diagnosed pulmonary tuberculosis
3. Slow acetylator phenotype
4. Provided written informed consent
1) liver cirrhosis child pugh C; 2) alcoholism or alcohol drinking 14 days before enrollment abnormal liver function test at baseline; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN); 3) herbal medicine used; 4)HIV infection; 5) Chronic kidney disease define as eGFR < 30; 6) severe tuberculosis with high risk of poor outcome e.g., acute respiratory failure; 7) any conditions that may contribute unfavorable outcome; 8) life-threatening condition such as sepsis, respiratory failure, congestive heart failure; 9) body weight < 35 Kg and > 80 Kg; 10) pregnant and lactating woman.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method drug-induced liver injury (DILI) 2,4,8 weeks Blood ALT or AST level more than 3 times ULN with hepatitis symptoms or more than 5 times ULN in the absence of symptoms.
- Secondary Outcome Measures
Name Time Method The proportion of sputum smear conversion 2,4,8 weeks Sputum AFB smear,The proportion of sputum culture conversion 8 weeks Sputum culture for TB,clinical symptoms score 2,4,8 weeks symptoms profile score questinair,Adverse drug reactions 2,4,8 weeks medical history and physical examination