Ceftobiprole in the Treatment of Patients With Community-Acquired Pneumonia
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| ClinicalTrials.gov Identifier: NCT00326287 |
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Recruitment Status :
Completed
First Posted : May 16, 2006
Last Update Posted : August 2, 2012
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Sponsor:
Basilea Pharmaceutica
Information provided by (Responsible Party):
Basilea Pharmaceutica
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia | Drug: Ceftobiprole medocaril Drug: Ceftriaxone with or without Linezolid | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 638 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Placebo in the Treatment of Subjects Hospitalized With Community-Acquired Pneumonia |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | July 2007 |
| Actual Study Completion Date : | July 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
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Drug: Ceftobiprole medocaril |
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Active Comparator: Ceftriaxone with or without Linezolid
Ceftriaxone 2g qd as 0.5h infusions with or without Linezolid 600mg q12h as 1h infusions, 7-14d
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Drug: Ceftriaxone with or without Linezolid |
Primary Outcome Measures :
- 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 Outcome Measures :
- Microbiological eradication rate (ratio of the number of patients with microbiological eradication to the total number of patients) [ Time Frame: 7 weeks ]
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| 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 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
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): NCT00326287
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: | NCT00326287 |
| Other Study ID Numbers: |
CR011407 30982081-CAP-3001 ( Other Identifier: Basilea Pharmaceutica International Ltd. ) |
| First Posted: | May 16, 2006 Key Record Dates |
| Last Update Posted: | August 2, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Basilea Pharmaceutica:
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Community-Acquired Pneumonia Cephalosporins Methicillin-Resistant Staphylococcus Aureus |
Additional relevant MeSH terms:
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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Ceftriaxone Linezolid Ceftobiprole |
Ceftobiprole medocaril Third Generation Cephalosporins Beta Lactam Antibiotics Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |