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