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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00770978
First received: October 9, 2008
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
ICU
Drug: ceftobiprole q12h
Drug: ceftobiprole q8h
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety will be evaluated throughout the study. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770978

Locations
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
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00770978     History of Changes
Other Study ID Numbers: CR014911, NOS-1001
Study First Received: October 9, 2008
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
ICU

Additional relevant MeSH terms:
Ceftobiprole
Ceftobiprole medocaril
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014