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

This study has been completed.
Information provided by (Responsible Party):
E-DA Hospital Identifier:
First received: September 14, 2009
Last updated: April 14, 2015
Last verified: April 2015
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis

Resource links provided by NLM:

Further study details as provided by E-DA Hospital:

Primary Outcome Measures:
  • To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment [ Time Frame: two year ]

Secondary Outcome Measures:
  • To compare the efficacy of anti-TB treatment between using FDC and single drugs [ Time Frame: two year ]

Enrollment: 161
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Separate anti-TB drugs
Fix-dosed combination anti-TB drugs


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Newly diagnosed TB patients in E-DA hospital

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
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Please refer to this study by its identifier: NCT00979290

E-DA hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
E-DA Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: E-DA Hospital Identifier: NCT00979290     History of Changes
Other Study ID Numbers: J120114933
Study First Received: September 14, 2009
Last Updated: April 14, 2015

Keywords provided by E-DA Hospital:
Fix-dose combination anti-TB drug
adverse effect

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on August 22, 2017