Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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Tuberculosis (TB) remains a leading health problem in both developing and developed countries. Despite the availability of effective chemotherapeutic 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. In the case of confirmed moderate or severe drug-induced hepatotoxicity, treatment should be interrupted and reintroduced after the hepatotoxicity has resolved. 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. We 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 our hospital.

Official Title
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Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment

Conditions
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Hepatitis, Tuberculosis, Pulmonary

Intervention / Treatment
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* Drug: isoniazid, rifampin, pyrazinamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard rechallenge, Slow rechallenge<br> | Drug: isoniazid, rifampin, pyrazinamide<br>* rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis<br>* Other names: PZA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrence of hepatitis |  | participants will be followed for the duration of hospital stay, an expected average of 5 weeks |