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

NCT00979290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 161

Last updated 2015-04-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • E-DA Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-11-30
Completion
2011-11-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00979290 on ClinicalTrials.gov