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
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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UNKNOWN
200 participants
OBSERVATIONAL
2009-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. No previous anti-TB drugs treatment
3. Age more than 18years old
Exclusion Criteria
2. Baseline AST and ALT \> 3 fold upper limit of normal (ULN) or total bilirubin\>2mg/dl
3. Age less than 18years old
18 Years
ALL
No
Sponsors
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E-DA Hospital
OTHER
Locations
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E-DA hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JTWu002
Identifier Type: -
Identifier Source: org_study_id
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