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NCT00326287 Clinical Trial

Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Pneumonia Clinical Trial

Official title:
A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00326287
Other study ID # CR011407
Secondary ID 30982081-CAP-300
Status Completed
Phase Phase 3
First received May 12, 2006
Last updated July 25, 2012
Start date June 2006
Est. completion date July 2007

Study information
Verified date July 2012
Source Basilea Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 638
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ceftobiprole medocaril

• Ceftriaxone with or without Linezolid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Basilea Pharmaceutica

Outcome
Type Measure Description Time frame Safety issue
Primary 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 7 weeks No
Secondary Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients) 7 weeks No
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