The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study

NCT ID: NCT01182259

Last Updated: 2010-08-16

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Brief Summary

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Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.

The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.

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

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 more than 18years old

Exclusion Criteria

1. Expected life \< 6months
2. Baseline AST and ALT \> 3 fold upper limit of normal (ULN) or total bilirubin\>2mg/dl
3. Age less than 18years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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E-DA Hospital

OTHER

Sponsor Role lead

Locations

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E-DA hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jiun-Ting Wu, MD

Role: CONTACT

886-7-615-0011 ext. 2980

Facility Contacts

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Chien-Tung Chiu

Role: primary

886-7-615-0011 ext. 2980

Other Identifiers

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JTWu002

Identifier Type: -

Identifier Source: org_study_id

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