Pharmacodynamic Parameters of Two Different Doses of Cefepime

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177736
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 13, 2007
Elan Pharmaceuticals
Information provided by:
University of Pittsburgh

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 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.

Condition or disease
Infection Bacteremia Pneumonia

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 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.

Study Type : Observational
Estimated Enrollment : 180 participants
Time Perspective: Prospective
Official Title: Pharmacodynamic Parameters of Two Different Doses of Cefepime
Study Start Date : September 2005
Actual Study Completion Date : December 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults of at least 18 years of age or older
  2. 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
  3. 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:

  1. Concomitant VAP or bacteremia with a cefepime resistant organism
  2. Concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside
  3. Patients requiring surgical or interventional drainage of purulent collections
  4. Pregnant or lactating women
  5. Dialysis patients
  6. Contraindication to blood sampling
  7. Cystic fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177736

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Elan Pharmaceuticals
Principal Investigator: David L Paterson, MD University of Pittsburgh

Responsible Party: David Paterson, MD, UPMC Identifier: NCT00177736     History of Changes
Other Study ID Numbers: IRB#0505059
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007

Keywords provided by University of Pittsburgh:
ventilator associated pneumonia

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents