Clinical trial NCT01395654: Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Official title: Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis
Tuberculosis, Pulmonary
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The duration needed for successfully rechallenge anti-tuberculosis treatment
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: Number of participants with recurrence of hepatitis
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chest Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Jann-Yuan Wang
role: PRINCIPAL_INVESTIGATOR
References: