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Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Primary Purpose

Infection

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

ceftazidime

About this trial

This is an interventional treatment trial for Infection focused on measuring ceftazidime, safety, infection

Eligibility Criteria

1 Year - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University Hospital

Outcomes

Primary Outcome Measures

The adverse drug reactions of ceftazidime

Secondary Outcome Measures

The effectiveness of ceftazidime

Full Information

NCT ID

NCT00173901

First Posted

September 12, 2005

Last Updated

September 13, 2005

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00173901

Brief Title

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Official Title

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

Study Type

Interventional

2. Study Status

Record Verification Date

January 2001

Overall Recruitment Status

Unknown status

Study Start Date

March 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection

Keywords

ceftazidime, safety, infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

536 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ceftazidime

Primary Outcome Measure Information:

Title

The adverse drug reactions of ceftazidime

Secondary Outcome Measure Information:

Title

The effectiveness of ceftazidime

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shan-Chwen Chang, MD PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Adverse Drug Reactions of Different Brands of Ceftazidime Injection

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