Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00326287
First received: May 12, 2006
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Ceftobiprole medocaril
Drug: Ceftriaxone with or without Linezolid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 638
Study Start Date: June 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
Drug: Ceftobiprole medocaril
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
Drug: Ceftriaxone with or without Linezolid

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00326287

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

Additional Information:
No publications provided by Basilea Pharmaceutica

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00326287     History of Changes
Other Study ID Numbers: CR011407, 30982081-CAP-3001
Study First Received: May 12, 2006
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:
Community-Acquired Pneumonia
Cephalosporins
Methicillin-Resistant Staphylococcus Aureus

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Linezolid
Ceftobiprole medocaril
Ceftobiprole
Cephalosporins
Ceftriaxone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on October 19, 2014