Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Overview

The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

Full Title of Study: “A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2007

Detailed Description

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of community-acquired pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Interventions

  • Drug: Ceftobiprole medocaril
  • Drug: Ceftriaxone with or without Linezolid

Arms, Groups and Cohorts

  • Experimental: Ceftobiprole medocaril
    • Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
  • Active Comparator: Ceftriaxone with or without Linezolid
    • Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d

Clinical Trial Outcome Measures

Primary Measures

  • Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug
    • Time Frame: 7 weeks

Secondary Measures

  • Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)
    • Time Frame: 7 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients suffering from community-acquired pneumonia severe enough to require hospitalization – Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study Exclusion Criteria:

  • Patients with known or suspected hypersensitivity to any related antibiotic medications – Treatment with any experimental drug within 30 days before enrollment – Prior enrollment in this study or any study with ceftobiprole medocaril

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

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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