Adverse Drug Reactions of Different Brands of Ceftazidime Injection - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The adverse drug reactions of ceftazidime

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00173901 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The effectiveness of ceftazidime

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Official Title ^ICMJE

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Infection

Intervention ^ICMJE

Drug: ceftazidime

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

536

Completion Date

April 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

less than 1 year old

Gender

Both

Ages

1 Year to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00173901

Responsible Party

Study ID Numbers ^ICMJE

900104

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Shan-Chwen Chang, MD PhD

National Taiwan University Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP