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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00177814
Other study ID # IRB # 0508074
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2005
Est. completion date June 2017

Study information

Verified date June 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary dead or alive health status end of study
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