Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
NCT ID: NCT01677871
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2HRZE/4HR
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
2HRLE/4HR
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
2HRLE/4HR
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
2HRZE/4HR
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
Interventions
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2HRZE/4HR
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
2HRLE/4HR
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Dr Naveen Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Dr Ankit Bhardwaj
Role: primary
Other Identifiers
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ILBS-ATT-01
Identifier Type: -
Identifier Source: org_study_id