Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

Basilea Pharmaceutica

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Ceftriaxone with or without Linezolid; Drug: Ceftobiprole medocaril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326287

30982081-CAP-3001 (Other Identifier)

CR011407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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638 participants in 2 patient groups

Ceftobiprole medocaril

Experimental group

Description:

Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d

Treatment:

Drug: Ceftobiprole medocaril

Ceftriaxone with or without Linezolid

Active Comparator group

Description:

Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d

Treatment:

Drug: Ceftriaxone with or without Linezolid