Overview

This trial is active, not recruiting.

Condition infection
Treatment ceftazidime
Phase phase 4
Sponsor National Taiwan University Hospital
Start date March 2001
End date April 2002
Trial size 536 participants
Trial identifier NCT00173901, 900104

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
The adverse drug reactions of ceftazidime
time frame:

Secondary Outcomes

Measure
The effectiveness of ceftazidime
time frame:

Eligibility Criteria

Male or female participants from 1 year up to 95 years old.

Inclusion Criteria: - patients in surgical intensive care unit who require ceftazidime treatment Exclusion Criteria: - less than 1 year old

Additional Information

Official title Adverse Drug Reactions of Different Brands of Ceftazidime Injection
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.