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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
781

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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