Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
- Registration Number
- NCT00770978
- Lead Sponsor
- Basilea Pharmaceutica
- 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 evaluated.
- 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 parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftobiprole q12h ceftobiprole q12h Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 Ceftobiprole q8h ceftobiprole q8h Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
- Primary Outcome Measures
Name Time Method Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose 3 days
- Secondary Outcome Measures
Name Time Method Safety will be evaluated throughout the study. 7 days