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

NCT ID: NCT00210899

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

828 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-10-31

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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in 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 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).

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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Vancomycin plus Ceftazidime

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

Group Type ACTIVE_COMPARATOR

Vancomycin plus Ceftazidime

Intervention Type DRUG

Ceftobiprole medocaril

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

Group Type EXPERIMENTAL

ceftobiprole medocaril

Intervention Type DRUG

Interventions

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ceftobiprole medocaril

Intervention Type DRUG

Vancomycin plus Ceftazidime

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 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
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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Belgium Bulgaria Canada Costa Rica Czechia Estonia Hungary India Israel Latvia Lithuania Romania Russia South Africa South Korea Taiwan Ukraine United States

References

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Noel GJ, Bush K, Bagchi P, Ianus J, Strauss RS. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis. 2008 Mar 1;46(5):647-55. doi: 10.1086/526527.

Reference Type RESULT
PMID: 18225981 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=630&filename=CR005029_CSR.pdf

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

Other Identifiers

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BAP00414

Identifier Type: OTHER

Identifier Source: secondary_id

CR005029

Identifier Type: -

Identifier Source: org_study_id