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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by E-DA Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT00979290
First received: September 14, 2009
Last updated: September 16, 2009
Last verified: September 2009
  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 ]

Estimated Enrollment: 200
Study Start Date: October 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979290

Contacts
Contact: Yung Fa Lai, MD 886-7-615-0011 Yungfa.lai@msa.hinet.net

Locations
Taiwan
E-DA hospital Recruiting
Kaohsiung, Taiwan
Contact: Jiun-Ting Wu, MD    886-7-615-0011    jt600729@ms13.hinet.net   
Principal Investigator: Yung Fa Lai, MD         
Sponsors and Collaborators
E-DA Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00979290     History of Changes
Other Study ID Numbers: J120114933
Study First Received: September 14, 2009
Last Updated: September 16, 2009
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
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014