Ceftobiprole in Hospital Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00210964
First received: September 13, 2005
Last updated: August 27, 2012
Last verified: August 2012

September 13, 2005
August 27, 2012
April 2005
May 2007   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00210964 on ClinicalTrials.gov Archive Site
  • Microbiological eradication rate [ Time Frame: At the TOC visit defined as 7-14 days after the EOT ] [ Designated as safety issue: No ]
  • Clinical cure rate [ Time Frame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT ] [ Designated as safety issue: No ]
  • Microbiological eradication rates [ Time Frame: At the LFU visit defined as 28 to 35 days after the EOT ] [ Designated as safety issue: No ]
  • Pneumonia-specific mortality rates [ Time Frame: Within 30 days after randomization ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Ceftobiprole in Hospital Acquired Pneumonia
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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pneumonia
  • 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
  • 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
  • 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
    Intervention: Drug: ceftobiprole plus placebo
  • 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
    Intervention: Drug: linezolid plus ceftazidime
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
781
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00210964
CR005032, BAP00307
Yes
Basilea Pharmaceutica
Basilea Pharmaceutica
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Basilea Pharmaceutica
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP