NCT00167986

Brief Summary

To determine whether the restriction of 3rd generation cephalosporins and carbapenems contribute to the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a medical intensive care unit (MICU).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

Escherichia Coli InfectionsKlebsiella Infections

Keywords

Bacterial Infections

Interventions

vancomycin-resistant enterococci and ESBLDRUG

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 MICU.
  • Patients 18 years of age or older.
  • Provide written informed consent.

You may not qualify if:

  • Patients known to be infected or colonized by VRE or ESBL-producing E.coli, K.pneumoniae.
  • Patients who have hypersensitivity to penicillin.
  • Any underlying conditions or diseases that will be ultimately fatal within 48 hours.
  • Any concurrent condition or medication which would interfere with absorption or metabolism of study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gyunggi-do, 431-070, South Korea

Location

MeSH Terms

Conditions

Escherichia coli InfectionsKlebsiella InfectionsBacterial Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial Infections and MycosesInfections

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(1)