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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770978

Enrollment

Registered

2008-10-10

Start date

2008-11-30

Completion date

2010-09-30

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU

Keywords

ICU

Brief 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

Interventions

DRUGceftobiprole q12h

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

DRUGceftobiprole q8h

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
Safety will be evaluated throughout the study.	7 days

Countries

Belgium, Canada, Israel, South Korea, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026