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

Skin Diseases, Infectious Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228982
• Other study ID #: CR005038
• Secondary ID: BAP00154
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: July 25, 2012
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2012
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases
• Skin Diseases, Bacterial
• Skin Diseases, Infectious
• Staphylococcal Skin Infections

Intervention

Drug:
• Ceftobiprole medocaril

• Vancomycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.		7 weeks	No
Secondary	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.		7 weeks	No