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

NCT ID: NCT00228982

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

784 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Skin Diseases, Infectious Skin Diseases, Bacterial Staphylococcal Skin Infections

Keywords

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Complicated Skin Infections Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Cephalosporin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ceftobiprole medocaril

Ceftobiprole medocaril 500mg q12h as 1h infusion, 7-14d

Group Type EXPERIMENTAL

Ceftobiprole medocaril

Intervention Type DRUG

Vancomycin

Vancomycin 1g q12h as 1h infusion, 7-14d

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Interventions

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Ceftobiprole medocaril

Intervention Type DRUG

Vancomycin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries

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Mexico United States

Other Identifiers

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BAP00154

Identifier Type: OTHER

Identifier Source: secondary_id

CR005038

Identifier Type: -

Identifier Source: org_study_id