Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs
- Conditions
- Tuberculosis
- Registration Number
- NCT00979290
- Lead Sponsor
- E-DA Hospital
- Brief Summary
The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- Newly diagnosed pulmonary TB and extrapulmonary TB patients
- No previous anti-TB drugs treatment
- Age≥18years old
- Expected life < 6months
- Baseline AST/ALT > 3x upper limit of normal (ULN)
- Age <18years old
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment two year
- Secondary Outcome Measures
Name Time Method To compare the efficacy of anti-TB treatment between using FDC and single drugs two year
Trial Locations
- Locations (1)
E-DA hospital
🇨🇳Kaohsiung, Taiwan