Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00228982

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.

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

MedlinePlus related topics: Skin Conditions

Drug Information available for: Ceftobiprole Ceftobiprole Medocaril

U.S. FDA Resources

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 as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	790
Study Start Date:	October 2004
Estimated Study Completion Date:	November 2005

Detailed 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 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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228982

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

No publications provided

Study ID Numbers:	CR005038
Study First Received:	September 27, 2005
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00228982 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Cephalosporins
Staphylococcal Infections
Gram-Positive Bacterial Infections

Skin Diseases, Infectious
Skin Diseases
Skin Diseases, Bacterial
Cefixime
Staphylococcal Skin Infections

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Cephalosporins
Anti-Infective Agents
Skin Diseases
Staphylococcal Skin Infections
Infection

Pharmacologic Actions
Staphylococcal Infections
Anti-Bacterial Agents
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial
Therapeutic Uses

ClinicalTrials.gov processed this record on May 07, 2009