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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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ICU

Intervention / Treatment
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* Drug: ceftobiprole q12h
* Drug: ceftobiprole q8h


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftobiprole q12h<br>Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 | Drug: ceftobiprole q12h<br>* Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2<br>|
| Experimental: Ceftobiprole q8h<br>Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2 | Drug: ceftobiprole q8h<br>* Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated throughout the study. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU