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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Peninsula Pharmaceuticals, Inc. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00515034 |
The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection
Condition | Intervention | Phase |
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Abscess, Intra-Abdominal Pneumonia, Ventilator-Associated Pneumonia Pneumonia, Bacterial Abscess |
Drug: Doripenem Drug: Imipenem/cilastatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Doripenem Compared With Imipenem in the Treatment of Subjects With Complicated Intra-Abdominal Infections or Ventilator Associated Pneumonia |
Estimated Enrollment: | 250 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Doripenem
1 gram intravenously every 8 hours for 5-14 days
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002: Active Comparator |
Drug: Imipenem/cilastatin
1 gram intravenously every 8 hours for 5-14 days
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This randomized (study drug assigned by chance), open-label, multicenter study will evaluate the safety and tolerability of doripenem in the treatment of patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Study drug will be administered intravenously (through a vein) for a maximum of 14 days for both indications. Specifically, the target is 7-14 days for patients with VAP and 5-14 days for patients with cIAI. The primary endpoint of this study is to assess the safety and tolerability of doripenem as measured by the overall incidence of treatment-emergent adverse events. The hypothesis for this study is that doripenem has a similar safety profile to imipenem.
Doripenem IV will be administered for a duration of 7 to 14 days for patients with ventilator-associated pneumonia and 5 to 14 days for patients with complicated intra-abdominal infection.
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. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Franchise Medical Leader ) |
Study ID Numbers: | CR012934, DORINOS2001 |
Study First Received: | August 10, 2007 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00515034 |
Health Authority: | United States: Food and Drug Administration |
Nosocomial Intra-abdominal infection Ventilator-associated pneumonia |
Pneumonia Abscess Bacterial pneumonia |
Bacterial Infections Abdominal Abscess Pneumonia, Ventilator-Associated Inflammation Imipenem Respiratory Tract Diseases Respiratory Tract Infections |
Cilastatin Abscess Pneumonia, Bacterial Lung Diseases Suppuration Pneumonia Cross Infection |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Infection Pharmacologic Actions Protease Inhibitors |