Overview of recent studies of community-acquired pneumonia.
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 approximately 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.
Higgins
K
K
US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA. karen.higgins@fda.hhs.gov
Singer
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M
Valappil
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T
Nambiar
S
S
Lin
D
D
Cox
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E
D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents