NCT01788449

Brief Summary

Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

August 6, 2009

Last Update Submit

February 12, 2013

Conditions

Bacterial Infections

Keywords

Antibiotic Bacterial Resistance

Outcome Measures

Primary Outcomes (1)

  • Endpoints will be efficacy of piperacillin/tazobactam in reducing colonization rates and infection of E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus

    8 months

Secondary Outcomes (1)

  • Endpoints will be acquisition and infection rate of ESBL producing E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus

    8 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive Care Unit (ICU)

All patients admitted in ICU will be enrolled (who qualify for treatment).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2009

First Posted

February 11, 2013

Study Start

May 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

February 13, 2013

Record last verified: 2013-02