Adverse Drug Reactions of Different Brands of Ceftazidime Injection

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: September 13, 2005 History of Changes

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00173901

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 IV

Drug Information available for: Ceftazidime

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	Adverse Drug Reactions of Different Brands of Ceftazidime Injection

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

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

Keywords provided by National Taiwan University Hospital:

ceftazidime
safety
infection

Study placed in the following topic categories:

Ceftazidime
Anti-Bacterial Agents
Drug Toxicity
Poisoning
Disorders of Environmental Origin

Additional relevant MeSH terms:

Ceftazidime
Anti-Infective Agents
Anti-Bacterial Agents
Drug Toxicity
Therapeutic Uses

Poisoning
Disorders of Environmental Origin
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009