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NCT Number: NCT00228982

Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus 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.

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Key information

Conditions

Skin Diseases, Infectious Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ceftobiprole medocaril

Drug

Vancomycin

Drug

Primary outcomes

  1. Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.

    Time frame: 7 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 29, 2005
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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