Ceftobiprole in Hospital Acquired Pneumonia
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00210964 |
|
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : September 3, 2012
|
Sponsor:
Basilea Pharmaceutica
Information provided by (Responsible Party):
Basilea Pharmaceutica
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia | Drug: ceftobiprole plus placebo Drug: linezolid plus ceftazidime | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 781 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia |
| Study Start Date : | April 2005 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | May 2007 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
Primary Outcome Measures :
- 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) ]
Secondary Outcome Measures :
- Microbiological eradication rate [ Time Frame: 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 ]
- Microbiological eradication rates [ Time Frame: At the LFU visit defined as 28 to 35 days after the EOT ]
- Pneumonia-specific mortality rates [ Time Frame: Within 30 days after randomization ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210964
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Basilea Pharmaceutica |
| ClinicalTrials.gov Identifier: | NCT00210964 |
| Other Study ID Numbers: |
CR005032 BAP00307 ( Other Identifier: Basilea ) |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | September 3, 2012 |
| Last Verified: | August 2012 |
Keywords provided by Basilea Pharmaceutica:
|
Ceftobiprole medocaril Nosocominal Pneumonia Ventilator-Associated Pneumonia Cephalosporins Methicillin-Resistant Staphylococcus Aureus |
Additional relevant MeSH terms:
|
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Linezolid Ceftazidime Ceftobiprole |
Ceftobiprole medocaril Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Third Generation Cephalosporins Beta Lactam Antibiotics |