Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Infection Clinical Trial

Official title:

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00173901
• Other study ID #: 900104
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 13, 2005
• Start date: March 2001
• Est. completion date: April 2002

Study information

• Verified date: January 2001
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 536
• Est. completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 95 Years

Eligibility

Inclusion Criteria:

• patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

• less than 1 year old

Study Design

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Infection

Intervention

Drug:
• ceftazidime

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The adverse drug reactions of ceftazidime
Secondary	The effectiveness of ceftazidime