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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
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring ceftazidime, safety, infection

Eligibility Criteria

1 Year - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
September 13, 2005
Sponsor
National Taiwan University Hospital
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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

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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

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