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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173901
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: January 2001
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   1 Year to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00173901     History of Changes
Other Study ID Numbers: 900104
Study First Received: September 12, 2005
Last Updated: September 13, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
ceftazidime
safety
infection

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders
Ceftazidime
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013