effect of adjunctive NAC for reducing hepatitis from anti-tuberculosis during intensive phase of treatment Anti-tuberculosis therapy induced liver injury (ATLI) anti-tuberculosis drug-induced liver injury (AT-DILI), Drug-induced liver injury, Pulmonary tuberculosis, Extra-pulmonary Tuberculosis, N-acetylcysteine (NAC)
Conditions
Interventions
NAC (600) 1 tab po BID adjuctive to standard treatment of anti-tuberculosis (Isoniazid 5 mg/kg/d, Rifampicin 10 mg/kg/day, Pyrazinamide 25 mg/kg/day and Ethambutol 15 mg/kg/day) ,standard treatment of
Experimental Drug,No Intervention No treatment
Adjunctive N-acetylcysteine ,control
Sponsors
Rajavithi Hospital, Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient was diagnosed with pulmonary tuberculosis or extra-pulmonary tuberculosis with 1.1 Age more than 60 years old with or without comorbidities 1.2 Age more than 18 years old with comorbidities - comorbidities including poor controlled diabetes mellitus (HbA1C > 9), CKD stage more than 3B (eGFR < 45), compensated cirrhosis (child-pugh score A), chronic liver disease like chronic HBV or HCV infection, malnutrition and low body weight (BMI < 18 kg/m2), hypoalbuminemia (albumin level < 3.5 mg/dl), obesity (BMI > 30 kg/m2), and HIV infection regardless of CD4 level 2. No contraindication for Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol 3. The patient has given consent to participate in the research study.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or breastfeeding. 2. Patients with pre-existing hepatitis prior to initiation of anti-tuberculosis therapy, defined as having Aspartate aminotransferase (AST) levels >68 U/L or more than twice the upper normal limit, or Alanine aminotransferase (ALT) levels >110 U/L or more than twice the upper normal limit, or total bilirubin >1.5 mg/dL, according to the reference range of Rajavithi Hospital. The normal ranges are: AST 5 to 34 U/L and ALT 0 to 55 U/L. 3. Patients diagnosed with tuberculosis who have respiratory failure requiring endotracheal intubation. 4. Patients diagnosed with tuberculosis who have hypotension requiring vasopressor support, or who experienced cardiac arrest within the past 24 hours. 5. Patients who continue to consume alcohol while receiving anti-tuberculosis treatment. 6. Patients with a known hypersensitivity to N-acetylcysteine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hepatitis at 8 weeks of taking anti-tuberculosis during intensive phase at 8 weeks liver function test | — |
Secondary
| Measure | Time frame |
|---|---|
| reducing of inflammatory marker at 8 weeks hs-CRP | — |
Countries
Thailand
Contacts
Public ContactYoswanich Maiprasert
Rajavithi Hospital
Outcome results
None listed