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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2001 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173901
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Condition Intervention Phase
Infection Drug: ceftazidime Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The adverse drug reactions of ceftazidime

Secondary Outcome Measures:
  • The effectiveness of ceftazidime

Estimated Enrollment: 536
Study Start Date: March 2001
Estimated Study Completion Date: April 2002
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

  • less than 1 year old
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173901


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Shan-Chwen Chang, MD PhD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173901     History of Changes
Other Study ID Numbers: 900104
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: January 2001

Keywords provided by National Taiwan University Hospital:
ceftazidime
safety
infection

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents