Overview

Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease

Status:
Unknown status
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
During the Study: - Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required - The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients. - Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment. - Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required. - The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Treatments:
Antitubercular Agents
Ethambutol
Isoniazid
Levofloxacin
Ofloxacin
Rifampin
Criteria
Inclusion Criteria:

- Males or Females subjects aged 18-75 years.

- Subjects with chronic liver disease (cirrhosis)

- Pulmonary or extra-pulmonary tuberculosis.

- Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.

- consent and willingness to follow-up

Exclusion Criteria:

- Serum ALT>5times upper limit and serum bilirubin >3 mg/dl.

- Renal failure (serum creatinine>2mg/dl).

- Presence of hepatocellular carcinoma

- Alcoholic cirrhotic who continue to drink alcohol.

- Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.

- Known hypersensitivity to levofloxacin, other quinolones