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

Basilea Pharmaceutica

Status and phase: Completed; Phase 3

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections

Treatments: Drug: ceftobiprole medocaril; Drug: Vancomycin plus Ceftazidime

Study type: Interventional

Funder types: Industry

Identifiers

NCT00210899

BAP00414 (Other Identifier)

CR005029

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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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 patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. 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: 828 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 or other related anti-infective 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

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828 participants in 2 patient groups

Vancomycin plus Ceftazidime

Active Comparator group

Description:

Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d

Treatment:

Drug: Vancomycin plus Ceftazidime

Ceftobiprole medocaril

Experimental group

Description:

Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

Treatment:

Drug: ceftobiprole medocaril