The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Official Title

A Phase III Randomized Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Nosocomial Pneumonia

Conditions

  • Pneumonia

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

  • Primary Outcomes: Clinical cure rate (the ratio of the number of clinically cured subjects to the total number of patients in the population) at 7 to 14 days after the end of therapy.
  • Secondary Outcomes: Microbiological eradication rate at 7-14 days after the end of therapy; Clinical cure rate and microbiological relapse at late follow-up visit; All deaths due to pneumonia within 30 days after randomization

Study Start

March 2005

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

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

    Total Enrolment

    770 (expected)

    Contact Details

    • Nambour Qld, 4560, Australia; Not yet recruiting
    • Bedford Park/Adelaide, 5042, Australia; Recruiting
    • Fremantle Wa, 6160, Australia; Recruiting
    • Parkville, 3052, Australia; Not yet recruiting
    • Southport, 4215, Australia; Recruiting
    • Bedford Park, 5042, Australia; Recruiting