Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Overview

The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Full Title of Study: “Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2009

Detailed Description

Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours

Interventions

  • Drug: Ceftobiprole
    • Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Arms, Groups and Cohorts

  • Experimental: Ceftobiprole
    • Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused
    • Time Frame: 2 days

Secondary Measures

  • Safety will be evaluated throughout the study.
    • Time Frame: Study Duration

Participating in This Clinical Trial

Inclusion Criteria

  • Informed Consent
  • Between 18 and 75 years of age inclusive
  • VAP – 48 hours after onset of mechanical ventilation
  • 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

  • Renal impairment (CrCl < 80 mL/min)
  • Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
  • History of seizures
  • 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Basilea Pharmaceutica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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