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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

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ClinicalTrials.gov Identifier: NCT00173901
Recruitment Status : Unknown
Verified January 2001 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Condition or disease Intervention/treatment Phase
Infection Drug: ceftazidime Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Adverse Drug Reactions of Different Brands of Ceftazidime Injection
Study Start Date : March 2001
Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The adverse drug reactions of ceftazidime

Secondary Outcome Measures :
  1. The effectiveness of ceftazidime

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00173901     History of Changes
Other Study ID Numbers: 900104
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 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