NCT00173901

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
536

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

January 1, 2001

First QC Date

September 12, 2005

Last Update Submit

September 13, 2005

Conditions

Infection

Keywords

ceftazidimesafetyinfection

Outcome Measures

Primary Outcomes (1)

  • The adverse drug reactions of ceftazidime

Secondary Outcomes (1)

  • The effectiveness of ceftazidime

Interventions

ceftazidimeDRUG

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients in surgical intensive care unit who require ceftazidime treatment

You may not qualify if:

  • less than 1 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Infections

Interventions

Ceftazidime

Intervention Hierarchy (Ancestors)

CephaloridineCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shan-Chwen Chang, MD PhD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2001

Study Completion

April 1, 2002

Last Updated

September 15, 2005

Record last verified: 2001-01

Locations

TW(1)