Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Doripenem

Criteria

Inclusion Criteria:

• Patients are 18 years of age or older

• Admitted to Emory surgical intensive care unit (ICU) service

• Have a diagnosis of sepsis that requires empiric antimicrobial therapy

• Obtained written informed consent from the patient or a first-degree relative if the patient is unable to give informed consent due to his/her medical condition prior to initiation of any study procedure

Exclusion Criteria:

• Surgical ICU length of stay less than 24 hours

• Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated creatinine clearance of less than 50 mL/min)

• Pregnancy

• Known allergy to beta-lactam antibiotics

• Non-English-speaking patients