Ceftobiprole in Hospital Acquired Pneumonia

August 27, 2012 updated by: Basilea Pharmaceutica

A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

781

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
ceftobiprole plus placebo 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
Drug: ceftobiprole plus placebo
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
Active Comparator: 002
linezolid plus ceftazidime 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
Drug: linezolid plus ceftazidime
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
7 to 14 days after the end-of-therapy (EOT)

Secondary Outcome Measures

Outcome Measure
Time Frame
Microbiological eradication rate
Time Frame: At the TOC visit defined as 7-14 days after the EOT
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
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
At the LFU visit defined as 28 to 35 days after the EOT
Pneumonia-specific mortality rates
Time Frame: Within 30 days after randomization
Within 30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005032
  • BAP00307 (Other Identifier: Basilea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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