Ceftobiprole in the Treatment of Hospital-Acquired Pulmonary 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:	NCT00210964

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 nosocomial pneumonia.

Condition	Intervention	Phase
Pneumonia	Drug: ceftobiprole medocaril	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Methicillin Ceftobiprole medocaril Cefixime Methicillin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Nosocomial Pneumonia

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

Primary Outcome Measures:

Clinical cure rate (the ratio of the number of clinically cured subjects to the total number of patients in the population) at 7 to 14 days after the end of therapy.

Secondary Outcome Measures:

Microbiological eradication rate at 7-14 days after the end of therapy; Clinical cure rate and microbiological relapse at late follow-up visit; All deaths due to pneumonia within 30 days after randomization.

Estimated Enrollment:	770
Study Start Date:	March 2005
Study Completion Date:	May 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 nosocomial (hospital-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 nosocomial pneumonia. 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:

Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
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, and have a negative serum or urine pregnancy test at the screening

Exclusion Criteria:

Known or suspected hypersensitivity to any related antibiotic medications
Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
Treatment with any investigational drug within 30 days before enrollment
Prior enrollment to this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210964

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

Study ID Numbers:	CR005032
Study First Received:	September 13, 2005
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00210964
Health Authority:	United States: Food and Drug Administration

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

Methicillin-Resistant Staphylococcus Aureus
Ventilator-Associated Pneumonia
Nosocominal Pneumonia
Cephalosporins

Study placed in the following topic categories:

Cephalosporins
Methicillin
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Cefixime
Pneumonia, Ventilator-Associated
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009