Ceftobiprole in Hospital Acquired Pneumonia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Drug: ceftobiprole plus placebo Drug: linezolid plus ceftazidime |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia |
- 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 ]
- 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 ]
| Enrollment: | 781 |
| Study Start Date: | April 2005 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Basilea Pharmaceutica |
| ClinicalTrials.gov Identifier: | NCT00210964 History of Changes |
| Other Study ID Numbers: | CR005032, BAP00307 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Basilea Pharmaceutica:
|
Ceftobiprole medocaril Nosocominal Pneumonia Ventilator-Associated Pneumonia Cephalosporins Methicillin-Resistant Staphylococcus Aureus |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Ceftazidime Cephalosporins Linezolid |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013