Chest
Clinical InvestigationsPNEUMONIAAn Economic Evaluation of Sequential IV/po Moxifloxacin Therapy Compared to IV/po Co-amoxiclav With or Without Clarithromycin in the Treatment of Community-Acquired Pneumonia*
Section snippets
The TARGET Study
The TARGET study7 was a multinational, multicenter, randomized, open-label, phase III clinical trial designed to examine the safety and efficacy of sequential IV/po moxifloxacin compared to a standard regimen of sequential IV/po co-amoxiclav with or without clarithromycin (IV or oral). The study population was adult patients newly hospitalized with radiologic evidence of CAP and requiring initial parenteral therapy. Exclusion criteria included the presence of coexisting disease considered
Primary Clinical Outcomes
A total of 622 study patients with clinical signs and symptoms, including radiology, confirming the CAP diagnosis were included in the economic analysis. More than half of the patients had a diagnosis of severe CAP according to the 1993 American Thoracic Society criteria.22 The mean ages of patients in the moxifloxacin and AMC ± CLA groups were 55.2 years and 55.9 years, respectively; a total of 64.1% and 64.5% of patients were male, 28% and 29% had preexisting bronchopulmonary disease, and 59%
Discussion
Our study has presented the results of a cost-effectiveness analysis in which the difference in costs and outcomes of moxifloxacin vs a standard antimicrobial therapy, AMC ± CLA, has been assessed in the treatment of patients with CAP from the perspectives of health-care payers in Germany and France. We believe that the conduct of the economic study as an integral part of the TARGET clinical trial7 adds to the validity of the economic conclusions. Germany and France represent two important
ACKNOWLEDGMENT
The authors thank the following people for contributing to this study: Jacqueline Gough and Dan Pericak of Innovus Research Inc., Burlington, ON, for statistical analysis; Professor Gérard de Pouvourville, INSERM U 537, Le Kremlin Bicêtre, France, for advice on costing methods for France; Karine Séjean, of the Faculté de Médecine, Saint-Antoine, Paris, for costing of resource items for that country; and Felicitas Ku¨hne, a consultant to Innovus, for costing of resource items for Germany.
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The current study was fully supported financially by Bayer and conducted by Innovus Research Inc., an independent contract research organization under the direction of Michael Drummond. Clinical outcomes were based on the report of the TARGET study designed and conducted by Bayer.
Dr. Rolf Kubin, a clinician employed by Bayer and experienced in the treatment of CAP in Europe, provided input as required throughout the study. Analyses of cost and cost-effectiveness were conducted by Innovus Research Inc., and a project team including individuals from Innovus and Bayer reviewed the analysis plan, study report and manuscript, and agreed by consensus on final manuscript content.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: [email protected]).