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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT00979290
First received: September 14, 2009
Last updated: April 14, 2015
Last verified: April 2015
  Purpose

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
Tuberculosis

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the efficacy of anti-TB treatment between using FDC and single drugs [ Time Frame: two year ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
Separate anti-TB drugs
Fix-dosed combination anti-TB drugs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Newly diagnosed TB patients in E-DA hospital

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00979290

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

No publications provided

Responsible Party: E-DA Hospital
ClinicalTrials.gov Identifier: NCT00979290     History of Changes
Other Study ID Numbers: J120114933
Study First Received: September 14, 2009
Last Updated: April 14, 2015
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on April 16, 2015