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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979290
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
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.

Condition or disease

Study Type : Observational
Actual Enrollment : 161 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Separate anti-TB drugs
Fix-dosed combination anti-TB drugs

Primary Outcome Measures :
  1. 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 :
  1. To compare the efficacy of anti-TB treatment between using FDC and single drugs [ Time Frame: two year ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979290

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

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
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 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