Clinical and microbiological end points in the treatment of pneumonia.
The US Food and Drug Administration is reviewing its criteria for evaluating new antibiotics for the treatment of bacterial pneumonia. Although there are descriptions of hundreds of comparative studies of various antimicrobials, there is surprisingly little scientific literature on how the evaluations should be done. This brief contribution outlines areas for further consideration as new drugs are evaluated.
Musher
Daniel M
DM
Medical Service, Infectious Disease Section, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D015415:Biomarkers; D002986:Clinical Trials as Topic; D017714:Community-Acquired Infections / Q000188:drug therapy*; D006801:Humans; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D015415:Biomarkers