Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

July 25, 2012 updated by: Basilea Pharmaceutica

A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.

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 complicated skin and skin structure infections. 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 complicated skin and skin structure infections. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Study Type

Interventional

Enrollment (Actual)

784

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:

  • Diagnosis of an infection consistent with complicated skin and skin structure infections.

Exclusion Criteria:

  • Known or suspected hypersensitivity to any study medication
  • Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
  • Previous enrollment in this study
  • Treatment with any investigational drug within 30 days before enrollment.

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 q12h as 1h infusion, 7-14d
Drug: Ceftobiprole medocaril
Active Comparator: Vancomycin
Vancomycin 1g q12h as 1h infusion, 7-14d
Drug: Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.
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

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

October 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

July 26, 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

  • CR005038
  • BAP00154 (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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