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

July 27, 2012 updated by: Basilea Pharmaceutica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Beech Grove, Indiana, United States
    • Nebraska
      • Omaha, Nebraska, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine) during dosing and 24 hours after last dose
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety will be evaluated throughout the study.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (ESTIMATE)

October 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014911
  • NOS-1001 (OTHER: Basilea Internal Reference)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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