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Adverse Drug Reactions of Different Brands of Ceftazidime Injection
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2001 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
National Taiwan University Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173901
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: January 2001
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Purpose
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
| Condition | Intervention | Phase |
|---|---|---|
| Infection | Drug: ceftazidime | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment |
| Official Title: | Adverse Drug Reactions of Different Brands of Ceftazidime Injection |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- The adverse drug reactions of ceftazidime
Secondary Outcome Measures:
- The effectiveness of ceftazidime
| Estimated Enrollment: | 536 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | April 2002 |
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| Ages Eligible for Study: | 1 Year to 95 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients in surgical intensive care unit who require ceftazidime treatment
Exclusion Criteria:
- less than 1 year old
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00173901
Please refer to this study by its ClinicalTrials.gov identifier: NCT00173901
Locations
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
| Study Chair: | Shan-Chwen Chang, MD PhD | National Taiwan University Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00173901 History of Changes |
| Other Study ID Numbers: |
900104 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 13, 2005 |
Keywords provided by National Taiwan University Hospital:
|
ceftazidime safety infection |
Additional relevant MeSH terms:
|
Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Ceftazidime Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on August 18, 2017