Pharmacodynamic Parameters of Two Different Doses of Cefepime

NCT00177736 | Completed

• 1 other identifier: IRB#0505059
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Bacteremia; Pneumonia

Keywords

ventilator associated pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 & Collaborators

• University of Pittsburgh: lead
• Elan Pharmaceuticals: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Infections; Bacteremia; Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• David L Paterson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Study Completion: December 1, 2007
• Last Updated: December 13, 2007

Record last verified: 2007-12

Locations

US (1)