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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00770978
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Study Description
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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.

Condition or disease Intervention/treatment Phase
ICU Drug: ceftobiprole q12h Drug: ceftobiprole q8h Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Parallel Group, Multiple-dose Study of Ceftobiprole to Evaluate the Plasma Pharmacokinetics in Adults in Intensive Care Units
Study Start Date : November 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceftobiprole q12h
Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
 Drug: ceftobiprole q12h
Ceftobiprole, 1G q12h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
Experimental: Ceftobiprole q8h
Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2
 Drug: ceftobiprole q8h
Ceftobiprole, 1G q8h as 4 hour infusions, on Day 1 and Ceftobiprole, 1G as single 4 hour infusion on Day 2


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Safety will be evaluated throughout the study. [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770978


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Beech Grove, Indiana, United States
United States, Nebraska
Omaha, Nebraska, United States
Belgium
Aalst, Belgium
Edegem, Belgium
Canada, Quebec
Greenfield Park N/A, Quebec, Canada
Israel
Jerusalem, Israel
Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Spain
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00770978    
Other Study ID Numbers: CR014911
NOS-1001 ( Other Identifier: Basilea Internal Reference )
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
Keywords provided by Basilea Pharmaceutica:
ICU
Additional relevant MeSH terms:
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Ceftobiprole
Ceftobiprole medocaril
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents