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Pharmacodynamic Parameters of Two Different Doses of Cefepime

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177736
First Posted: September 15, 2005
Last Update Posted: December 13, 2007
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.
Collaborator:
Elan Pharmaceuticals
Information provided by:
University of Pittsburgh
  Purpose
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 Phase
Infection Bacteremia Pneumonia Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pharmacodynamic Parameters of Two Different Doses of Cefepime

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 180
Study Start Date: September 2005
Study Completion Date: December 2007
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.
  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00177736


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

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

Keywords provided by University of Pittsburgh:
ventilator associated pneumonia

Additional relevant MeSH terms:
Pneumonia
Bacteremia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents