NCT00478855

Brief Summary

  1. 1.To determine the value of using piperacillin/tazobactam in reducing the cases of extended spectrum beta lactamases (ESBL) producing E. coli or K. pneumoniae colonization and infection.
  2. 2.To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre-and post-intervention in the selected medical centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

May 24, 2007

Last Update Submit

December 7, 2007

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention)

Secondary Outcomes (1)

  • The infection rate due to ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months; post-intervention)

Interventions

Tazocin (Piperacillin/Tazobactem)DRUG

Eligibility Criteria

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

You may qualify if:

  • All patients admitted or transferred to the ICU/pulmonary/Infection units
  • Patients of either sex, 18 years of age or older Patients who stay in units less than 48 hours will not be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, 100730, China

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Piperacillin, Tazobactam Drug CombinationPiperacillin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

September 1, 2006

Study Completion

June 1, 2007

Last Updated

December 10, 2007

Record last verified: 2007-12

Locations

CN(1)