Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs
Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
1 other identifier
observational
161
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 14, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedApril 16, 2015
April 1, 2015
1.1 years
September 14, 2009
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
two year
Secondary Outcomes (1)
To compare the efficacy of anti-TB treatment between using FDC and single drugs
two year
Study Arms (2)
Separate anti-TB drugs
Fix-dosed combination anti-TB drugs
Eligibility Criteria
Newly diagnosed TB patients in E-DA hospital
You may qualify if:
- Newly diagnosed pulmonary TB and extrapulmonary TB patients
- No previous anti-TB drugs treatment
- Age≥18years old
You may not qualify if:
- Expected life \< 6months
- Baseline AST/ALT \> 3x upper limit of normal (ULN)
- Age \<18years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- E-DA Hospitallead
Study Sites (1)
E-DA hospital
Kaohsiung City, Taiwan
Related Publications (1)
Wu JT, Chiu CT, Wei YF, Lai YF. Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment. Clinics (Sao Paulo). 2015 Jun;70(6):429-34. doi: 10.6061/clinics/2015(06)08. Epub 2015 Jun 1.
PMID: 26106962DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2009
First Posted
September 17, 2009
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2011
Last Updated
April 16, 2015
Record last verified: 2015-04