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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00210964 |
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.
Condition | Intervention | Phase |
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Pneumonia |
Drug: ceftobiprole medocaril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Nosocomial Pneumonia |
Estimated Enrollment: | 770 |
Study Start Date: | March 2005 |
Study Completion Date: | May 2007 |
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of nosocomial (hospital-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 nosocomial pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit.
The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005032 |
Study First Received: | September 13, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00210964 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Methicillin-Resistant Staphylococcus Aureus Ventilator-Associated Pneumonia Nosocominal Pneumonia Cephalosporins |
Anti-Infective Agents Anti-Bacterial Agents Cephalosporins Methicillin Respiratory Tract Infections |
Respiratory Tract Diseases Lung Diseases Cefixime Pneumonia, Ventilator-Associated Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Cephalosporins Respiratory Tract Infections Respiratory Tract Diseases |
Therapeutic Uses Lung Diseases Pharmacologic Actions Pneumonia |