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

Completed · Phase 1

Conditions studied: ICU

In brief

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.

Key facts

Study ID

NCT00770978

Run by

Basilea Pharmaceutica

People needed

33

Starts

2008-11-01

Expected to finish

2010-09-01

Last updated by the study team

2012-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Chicago, Illinois, United States
• Study site — Beech Grove, Indiana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Aalst, Belgium
• Study site — Edegem, Belgium
• Study site — Greenfield Park, Quebec, Canada
• Study site — Jerusalem, Israel
• Study site — Gwangju, South Korea
• Study site — Incheon, South Korea
• Study site — Seoul, South Korea
• Study site — Barcelona, Spain
• Study site — Madrid, Spain

Full record on ClinicalTrials.gov

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