NCT00770978

Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU

Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• ICU

Interventions

Type	Name	Description
DRUG	ceftobiprole q12h	Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
DRUG	ceftobiprole q8h	Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-10-10
• Last updated: 2012-07-30

Locations

13 sites across 6 countries: United States, Belgium, Canada, Israel, South Korea, Spain