Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia - 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:	NCT00326287

Purpose

The purpose of this study is to compare the clinical cure rate (ratio of clinically cured patients to the total number of patients) of ceftobiprole medocaril versus a comparator in the treatment of patients with community-acquired pneumonia.

Condition	Intervention	Phase
Pneumonia	Drug: Ceftobiprole medocaril	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftobiprole Ceftobiprole Medocaril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

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

Primary Outcome Measures:

Clinical cure rate (ratio of the number of clinically cured patients to the total number of patients) at the test of cure visit that occurs 7 to 14 days after the last dose of study drug

Secondary Outcome Measures:

Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)

Estimated Enrollment:	670
Study Start Date:	April 2006
Study Completion Date:	July 2007

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 community-acquired pneumonia. 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 community-acquired pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. Patients who meet specified criteria may be switched to an alternative oral treatment. The primary endpoint is that the clinical cure rate among patients treated with ceftobiprole at the test of cure visit.

The patients will receive either ceftobiprole medocaril plus placebo or a comparator.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients suffering from community-acquired pneumonia severe enough to require hospitalization
Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study

Exclusion Criteria:

Patients with known or suspected hypersensitivity to any related antibiotic medications
Treatment with any experimental drug within 30 days before enrollment
Prior enrollment in this study or any study with ceftobiprole medocaril

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326287

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:	CR011407
Study First Received:	May 12, 2006
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00326287 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Methicillin-Resistant Staphylococcus Aureus
Cephalosporins
Community-Acquired Pneumonia

Study placed in the following topic categories:

Anti-Bacterial Agents
Cephalosporins
Methicillin
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Cefixime
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Cephalosporins
Respiratory Tract Infections
Respiratory Tract Diseases

Therapeutic Uses
Lung Diseases
Pharmacologic Actions
Pneumonia

ClinicalTrials.gov processed this record on May 07, 2009