Tuberculosis, Pulmonary Clinical Trial
Official title:
Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment
Despite the availability of effective anti-tuberculosis agents that exist to treat this
illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as
isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use.
There is no consensus on method of the reintroduction of anti-TB medications. The risk of
reintroducing of a anti-TB medications could be hazardous. There are several differences
between the guidelines from the ATS, BTS and the Task Force of the European Respiratory
Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the
methods of reintroducing of anti-TB medications.
The investigators plan to do a prospective study to evaluate the outcome and safety of
reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment
among TB patients in the investigators hospital.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Hepatitis during anti-tuberculosis treatment - Hold RMP, INH and PZA after hepatitis - Age >= 18 years old - HIV(-) - T-bilirubin < 2.5 mg/dL - No allergy to RMP, INH and PZA Exclusion Criteria: - Liver cirrhosis, child B or C - Pregnancy and breast feeding - Life expectation < 1 year |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chest Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The duration needed for successfully rechallenge anti-tuberculosis treatment | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | Yes | |
Secondary | Number of participants with recurrence of hepatitis | participants will be followed for the duration of hospital stay, an expected average of 5 weeks | Yes |
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