Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit

NCT ID: NCT00177814

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2017-06-30

Brief Summary

The proposed endpoints of the study would be: comparative use of piperacillin versus broader spectrum agents (e.g., piperacillin/tazobactam, etc.) [measured as defined daily doses per 1000 patient days]; physician acceptance of piperacillin as part of a streamlining program [measured as successful occurrences of the use of piperacillin as streamlining therapy]; changes in susceptibility patterns of broad spectrum antibiotics [measured as % Gram negative bacilli susceptible to each of the commonly used broad spectrum antibiotics]; and outcome of patients treated with streamlined therapy.

Detailed Description

The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antibiotics once organism is identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history.

Conditions

Gram-negative Bacterial Infections

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with Gram negative infections treated with piperacillin/tazobactam and/or piperacillin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB # 0508074

Identifier Type: -

Identifier Source: org_study_id