- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173901
Adverse Drug Reactions of Different Brands of Ceftazidime Injection
September 13, 2005 updated by: National Taiwan University Hospital
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
Study Overview
Detailed Description
Ceftazidime is a third generation cephalosporins that should be reserved for severe bacterial infections. Substitution of the brand ceftazidime with a generic ceftazidime raised some concerns.
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
Study Type
Interventional
Enrollment
536
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 93 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients in surgical intensive care unit who require ceftazidime treatment
Exclusion Criteria:
- less than 1 year old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The adverse drug reactions of ceftazidime
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Secondary Outcome Measures
Outcome Measure |
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The effectiveness of ceftazidime
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Shan-Chwen Chang, MD PhD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Study Completion
April 1, 2002
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
January 1, 2001
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 900104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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