Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs

E-DA Hospital

Status: Completed

Conditions: Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT00979290

J120114933

Details and patient eligibility

About

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Age≥18years old

Exclusion criteria

1. Expected life < 6months
2. Baseline AST/ALT > 3x upper limit of normal (ULN)
3. Age <18years old

Trial design

161 participants in 2 patient groups

Separate anti-TB drugs

Fix-dosed combination anti-TB drugs