Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Primary Purpose
Infection
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
ceftazidime
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring ceftazidime, safety, infection
Eligibility Criteria
Inclusion Criteria: patients in surgical intensive care unit who require ceftazidime treatment Exclusion Criteria: less than 1 year old
Sites / Locations
- National Taiwan University Hospital
Outcomes
Primary Outcome Measures
The adverse drug reactions of ceftazidime
Secondary Outcome Measures
The effectiveness of ceftazidime
Full Information
NCT ID
NCT00173901
First Posted
September 12, 2005
Last Updated
September 13, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00173901
Brief Title
Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Official Title
Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
ceftazidime, safety, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
536 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ceftazidime
Primary Outcome Measure Information:
Title
The adverse drug reactions of ceftazidime
Secondary Outcome Measure Information:
Title
The effectiveness of ceftazidime
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in surgical intensive care unit who require ceftazidime treatment
Exclusion Criteria:
less than 1 year old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan-Chwen Chang, MD PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Adverse Drug Reactions of Different Brands of Ceftazidime Injection
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