Ceftobiprole in Hospital Acquired Pneumonia

Basilea Pharmaceutica781 enrolled

Overview

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to receive ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00307) and another similar study (BAP00248, see NCT00229008) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248. Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

781

Conditions

Pneumonia

Interventions

ceftobiprole plus placeboDRUG

ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days

linezolid plus ceftazidimeDRUG

linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)

Time frame: 7 to 14 days after the end-of-therapy (EOT)

Secondary Outcomes

Microbiological eradication rate

Time frame: At the TOC visit defined as 7-14 days after the EOT

Clinical cure rate

Time frame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT

Microbiological eradication rates

Time frame: At the LFU visit defined as 28 to 35 days after the EOT

Pneumonia-specific mortality rates

Time frame: Within 30 days after randomization

Data from ClinicalTrials.gov

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