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

Basilea Pharmaceutica logo

Basilea Pharmaceutica

Status and phase

Completed
Phase 3

Conditions

Skin Diseases, Infectious
Skin Diseases, Bacterial
Staphylococcal Skin Infections

Treatments

Drug: Ceftobiprole medocaril
Drug: Vancomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228982
CR005038
BAP00154 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

784 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

784 participants in 2 patient groups

Ceftobiprole medocaril
Experimental group
Description:
Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
Treatment:
Drug: Ceftobiprole medocaril
Vancomycin
Active Comparator group
Description:
Vancomycin 1g q12h as 1h infusion, 7-14d
Treatment:
Drug: Vancomycin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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