Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. |
---|---|
Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00236834 |
The purpose of this study is to compare the safety and effectiveness of levofloxacin with imipenem/cilastatin in the treatment of hospital-acquired pneumonia
Condition | Intervention | Phase |
---|---|---|
Nosocomial Pneumonia |
Drug: levofloxacin; imipenem/cilastitin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Open Label Study to Compare the Safety and Efficacy of Levofloxacin With That of Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia |
Estimated Enrollment: | 400 |
Study Start Date: | December 1997 |
Estimated Study Completion Date: | June 2001 |
Despite advances in prevention and treatment, hospital-acquired pneumonia remains a significant problem as the second most common infection acquired in the hospital and the most deadly (20%-50% of patients who acquire pneumonia while in the hospital die from complications of pneumonia). Levofloxacin has been shown in clinical trials to be effective against a number of different bacteria, including those found to be common and uncommon causes of pneumonia. This multicenter, open-label study evaluates the safety and effectiveness of levofloxacin as compared with imipenem/cilastatin, another type of antibiotic treatment, in patients with pneumonia acquired in the hospital. Patients receive treatment for a total of 7-15 days, initially with levofloxacin or imipenem/cilastatin, administered slowly through a vein. If patients respond positively to either drug, treatment may be changed to levofloxacin or ciprofloxacin (if initially treated with imipenem/cilastatin), to be taken by mouth. Certain additional drugs may be added if needed to treat pneumonia caused by certain bacteria. Patients showing signs of improvement continue in the study, with assessments 5-7 days (posttherapy visit) and 28-32 days after completion of the study drug (poststudy visit). Effectiveness is assessed by measuring the ability of the study drug to eliminate bacteria causing pneumonia and to reduce the signs and symptoms of pneumonia. Chest x-rays and laboratory tests for bacteria are performed throughout the study and patients' severity of disease is rated according to the Acute Physiology And Chronic Health Evaluation (APACHE) scale. Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. Blood samples are drawn from patients receiving levofloxacin to determine the concentration of levofloxacin in the blood. The study hypothesis is that levofloxacin is at least as effective as imipenem/cilastatin in treating hospital-acquired pneumonia and is generally well-tolerated.
Levofloxacin 750 mg administered through a vein once daily or imipenem/cilastatin 500mg-1 gram every 6-8 hours. Upon improvement, patients may transition to levofloxacin 750mg by mouth once daily or ciprofloxacin 750mg by mouth twice daily for 7-15 days.
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: | CR005557 |
Study First Received: | October 7, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00236834 |
Health Authority: | United States: Food and Drug Administration |
respiratory tract diseases pneumonia quinolones, hospital-acquired pneumonia lung diseases levofloxacin |
Respiratory Tract Infections Respiratory Tract Diseases Cilastatin Lung Diseases |
Ofloxacin Pneumonia Imipenem |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |