Status:
COMPLETED
Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
ICU
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evalua...
Detailed Description
Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of ceftobiprole in the plasma. Pharmacokinetic pa...
Eligibility Criteria
Inclusion
- Informed Consent
- Between 18 and 75 years of age inclusive
- BMI 18 - 35 inclusive
- Albumin \< 3.3 g/dL or clinical evidence of edema
- Negative Pregnancy test
- Expected survival of at least 7 days
Exclusion
- Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
- Renal impairment (CrCl \< 50 mL/min) or dialysis
- History of seizures
- ALT or AST \> 5 times upper normal limit
- Sustained shock, unresponsive to sympathomimetics
- Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00770978
Start Date
November 1 2008
End Date
September 1 2010
Last Update
July 30 2012
Active Locations (13)
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1
Birmingham, Alabama, United States
2
Chicago, Illinois, United States
3
Beech Grove, Indiana, United States
4
Omaha, Nebraska, United States