Status:
COMPLETED
Anti-tuberculosis (TB) Drug Levels and Correlation With Drug Induced Hepatotoxicity
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Hepatitis
Tuberculosis
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of rifampicin and other antituberculosis drugs and compare these drug levels in patients who develop drug indu...
Detailed Description
Tuberculosis (TB) is a major health problem in both the developing and developed countries because of its resurgence in the immunosuppressed patients. World Health Organization (WHO) in 1993 declared ...
Eligibility Criteria
Inclusion
- Age: patients in the range between 18 to 65 years
- Patients of either gender
- Probable or confirmed cases of TB
- Patients receiving daily antituberculosis drugs
Exclusion
- Patients with serological evidence of acute viral hepatitis A, B, C, or E and carriers of HBV and/or HCV
- HIV positive patients
- Presence of chronic liver disease or cirrhosis
- Cognitive dysfunction
- Terminally sick patients and unlikely to survive for 6-9 months
- Concomitant administration of other potentially hepatotoxic drugs(Methotrexate, Phenytoin, phenobarbitone, carbamazepine ,valproate Atenolol, labetalol, Salicylates , allopurinol, quinine, quinidine, fluconazole, cimetidine, ethionamide, verapamil, probenecid, TCA, halothane)
- Chronic alcoholics consuming \>48 g/day for more 1 year
- Patients not willing to give informed consent
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01456845
Start Date
August 1 2010
End Date
June 1 2012
Last Update
August 31 2012
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, India, 110029