Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs
Information source: E-DA Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Phase: N/A
Status: Recruiting
Sponsored by: E-DA Hospital Overall contact:
Yung Fa Lai, MD, Phone: 886-7-615-0011, Email: Yungfa.lai@msa.hinet.net
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.
Clinical Details
Official title: Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
Secondary outcome: To compare the efficacy of anti-TB treatment between using FDC and single drugs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Ageā„18years old
Exclusion Criteria:
1. Expected life < 6months
2. Baseline AST/ALT > 3x upper limit of normal (ULN)
3. Age <18years old
Locations and Contacts
Yung Fa Lai, MD, Phone: 886-7-615-0011, Email: Yungfa.lai@msa.hinet.net
E-DA hospital, Kaohsiung, Taiwan; Recruiting
Jiun-Ting Wu, MD, Phone: 886-7-615-0011, Email: jt600729@ms13.hinet.net
Yung Fa Lai, MD, Principal Investigator
Additional Information
Starting date: October 2008
Last updated: September 16, 2009
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