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

This study is not yet open for patient recruitment.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. September 2005

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00210899

Purpose

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.
Condition Intervention Phase
Staphylococcal Skin Infections
Skin Diseases, Infectious
Skin Diseases, Bacterial
 Drug: Ceftobiprole medocaril
Phase III

MedlinePlus related topics:  Bacterial Infections;   Skin Conditions;   Staphylococcal Infections

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy.
Secondary Outcomes: Microbiological eradication rate at 7-14 days after the end of therapy. Clinical cure rate and microbiological relapse rate at the late follow-up visit. Safety evaluations conducted during the study.
Expected Total Enrollment:  816

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).

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00210899

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial,  Study Director,  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.   

More Information

Study ID Numbers:  CR005029
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00210899
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us