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COMPLETEDPhase 1NCT00770978

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

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 evalua...

Lead sponsor: Basilea Pharmaceutica•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

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 years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 30, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment33

Start dateNov 2008

Last updatedJul 30, 2012

Condition

Locations shown

Birmingham, Alabama

Chicago, Illinois

Beech Grove, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2012Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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