Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

July 25, 2012 updated by: Basilea Pharmaceutica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

638

Phase

  • Phase 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Basilea Pharmaceutica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR011407
  • 30982081-CAP-3001 (Other Identifier: Basilea Pharmaceutica International Ltd.)

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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