Pharmacodynamic Parameters of Two Different Doses of Cefepime

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 antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. Based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the "susceptible" range. This study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.

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Key information

Conditions

Infection Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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 bacteremia will be invited to participate in the study. Blood samples will be taken to determine the pharmacokinetic profile of the drug. Blood cultures will be repeated in patients with bacteremia to determine clearance of infection. A mini-BAL will be repeated in patients with ventilator-associated pneumonia to determine clearance of pneumonia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

Elan Pharmaceuticals

Registry information

Important dates

Study start: 2005
Study completion: 2007
First posted: Sep 15, 2005
Registry last updated: Dec 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed