Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Basilea Pharmaceutica
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU
