Status:
COMPLETED
Pharmacodynamic Parameters of Two Different Doses of Cefepime
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Infection
Bacteremia
Eligibility:
All Genders
18+ years
Brief Summary
Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Mathematical models of antibioti...
Detailed Description
This will be a non-interventional study in that the antibiotic and its dose will be chosen by the treating team not the investigators. Patients on cefepime who have ventilator-associated pneumonia or ...
Eligibility Criteria
Inclusion
- Adults of at least 18 years of age or older
- Culture proven ventilator associated pneumonia (VAP) or bacteremia caused by a cefepime susceptible gram negative pathogen:
- Bacteremia is defined as at least one positive blood culture
- VAP is defined by at least 10,000 cfu/ml of an organism from a bronchoalveolar lavage sample
- Cefepime therapy (1 or 2 grams intravenously \[IV\] every \[q\] 8 hours or q 12 hours) initiated as part of standard of care
Exclusion
- Concomitant VAP or bacteremia with a cefepime resistant organism
- Concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside
- Patients requiring surgical or interventional drainage of purulent collections
- Pregnant or lactating women
- Dialysis patients
- Contraindication to blood sampling
- Cystic fibrosis
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00177736
Start Date
September 1 2005
End Date
December 1 2007
Last Update
December 13 2007
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213