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

NCT ID: NCT00979290

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Separate anti-TB drugs

No interventions assigned to this group

Fix-dosed combination anti-TB drugs

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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E-DA Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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E-DA hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 26106962 (View on PubMed)

Other Identifiers

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J120114933

Identifier Type: -

Identifier Source: org_study_id

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