NCT00167960

Brief Summary

To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

March 15, 2007

Status Verified

March 1, 2007

First QC Date

September 11, 2005

Last Update Submit

March 14, 2007

Conditions

Gram-Positive Bacterial Infections

Keywords

Bacterial Infections

Interventions

Piperacillin/tazobactam and other β-lactam/β-lactamaseDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to or transferred to the SICU.
  • Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
  • Provide written informed consent

You may not qualify if:

  • Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
  • Females who are pregnant and breast feeding
  • Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
  • Those who have already been participating other clinical study related with antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Incheon, 405-760, South Korea

Location

Unknown Facility

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Gram-Positive Bacterial InfectionsBacterial Infections

Interventions

PiperacillinTazobactam

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPenicillanic AcidSulfones

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Last Updated

March 15, 2007

Record last verified: 2007-03

Locations

KR(2)