NCT00488189

Brief Summary

This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 15, 2011

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

June 18, 2007

Last Update Submit

April 14, 2011

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • 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 of intervention phase)

    9 months

Secondary Outcomes (1)

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

    9 months

Study Arms (2)

1

NO INTERVENTION

baseline, collecting rectal swab samples

2

ACTIVE COMPARATOR

use pipercill/tazobact to replace 3rd generation cephalosporin and collect rectal swab

Drug: Tazocin (pipercillin/tazobactam)

Interventions

Tazocin (pipercillin/tazobactam)DRUG

over 50% third generation cephalosporin should be replaced by Pip/Taz

2

Eligibility Criteria

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

You may qualify if:

  • All patients admitted or transferred to ICU/Pulmonary units
  • Patients of either sex, 18 years of age or older

You may not qualify if:

  • \- 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, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Piperacillin, Tazobactam Drug CombinationPiperacillinTazobactam

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For China, medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 15, 2011

Record last verified: 2010-06

Locations

CN(1)