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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection

Intervention: ceftazidime (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Shan-Chwen Chang, MD PhD, Study Chair, Affiliation: National Taiwan University Hospital

Summary

The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Clinical Details

Official title: Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: The adverse drug reactions of ceftazidime

Secondary outcome: The effectiveness of ceftazidime

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

Minimum age: 1 Year. Maximum age: 95 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

- less than 1 year old

Locations and Contacts

National Taiwan University Hospital, Taipei 100, Taiwan
Additional Information

Starting date: March 2001
Last updated: September 13, 2005

Page last updated: August 23, 2015

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