Pharmacodynamic Parameters of Two Different Doses of Cefepime

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177736
• Collaborator: Elan Pharmaceuticals (Industry)
• Enrollment: 180
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Anticipated Enrollment: 180 participants
• Time Perspective: Prospective
• Official Title: Pharmacodynamic Parameters of Two Different Doses of Cefepime
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

1. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00177736
• Other Study ID Numbers: IRB#0505059
• First Posted: Sep 15, 2005
• Last Update Posted: Dec 13, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: ventilator associated pneumonia
• Additional relevant MeSH terms: Pneumonia; Bacteremia

Study Results

No Results Posted as of Dec 13, 2007