Journal Article

Overview of Recent Studies of Community-Acquired Pneumonia

K. Higgins, M. Singer, T. Valappil, S. Nambiar, D. Lin and E. Cox

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue Supplement_3, pages S150-S156
Published in print December 2008 | ISSN: 1058-4838
Published online December 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/591397
Overview of Recent Studies of Community-Acquired Pneumonia

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All recent studies of antibacterial drugs for the indication of community-acquired pneumonia submitted to the US Food and Drug Administration have been designed as noninferiority studies. We provide a summary of results of 7 recent clinical studies of oral antibacterial drugs for treatment of community-acquired pneumonia. In these 7 studies, the majority of patients enrolled had Pneumonia Patient Outcomes Research Team scores of I or II. The percentage of randomized subjects with pathogens identified at baseline ranged from 47% to 76%, and the percentage of subjects with Streptoccocus pneumoniae isolated at baseline ranged from ∼6% to 20%. The primary end point in these studies was clinical cure, assessed 7–21 days after completion of therapy. Clinical cure rates were >80% in the intent-to-treat populations and >90% in the per-protocol populations. We also briefly summarize the results from several recently submitted clinical studies of intravenously administered antibacterial drugs for treatment of community-acquired pneumonia, in which we found similar results.

Journal Article.  4498 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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