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Completed

NCT Number: NCT00326287

Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia

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.

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Key information

Conditions

Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ceftobiprole medocaril

Drug

Ceftriaxone with or without Linezolid

Drug

Primary outcomes

  1. 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

    Time frame: 7 weeks

Secondary outcomes

  1. Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients)

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 16, 2006
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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