Adverse Drug Reactions of Different Brands of Ceftazidime... | NCT00173901

Studies
Adverse Drug Reactions of Different Brands of Ceftazidime Injection

NCT00173901

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 15, 2005Estimated

Enrollment

536

Phase

Phase 4

Conditions

Infection

Interventions

ceftazidime

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2001

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Not provided

Completion Date

Apr 2002

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 15, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

536

Name	Type	Description	Arm Group Labels	Other Names
ceftazidime	Drug

Measure	Description	Time Frame
The adverse drug reactions of ceftazidime

Measure	Description	Time Frame
The effectiveness of ceftazidime

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

less than 1 year old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shan-Chwen Chang, MD PhD	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002442	Ceftazidime

Ancestor Terms

ID	Term
D002509	Cephaloridine
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams

Browse Leaves

Not provided

Browse Branches

Not provided