Hepatitis, Tuberculosis, Pulmonary
Conditions
Brief summary
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
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.
Interventions
DRUGisoniazid, rifampin, pyrazinamide
rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Taiwan
Contacts
Primary ContactJann-Yuan Wang, MD
Outcome results
None listed