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

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: ICU

Treatments: Drug: ceftobiprole q12h; Drug: ceftobiprole q8h

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770978

NOS-1001 (Other Identifier)

CR014911

Details and patient eligibility

About

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.

Full 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

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Ceftobiprole q12h

Experimental group

Description:

Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Treatment:

Drug: ceftobiprole q12h

Ceftobiprole q8h

Experimental group

Description:

Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2

Treatment:

Drug: ceftobiprole q8h