Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureus.
Given the changing epidemiology of disease due to Staphylococcus aureus (SA), including the emergence of drug-resistant organisms such as methicillin-resistant SA, investigators may wish to evaluate the effects of antimicrobials in disease due to SA as well as in disease due to other organisms in the same trial. Here we discuss issues that investigators should address in trial design, conduct, and analysis to evaluate overall effects or effects within subgroups according to causative organisms.
Powers
J H
JH
Scientific Applications International, in support of Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA. powersjohn@mail.nih.gov
Fleming
T R
TR
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards* / Q000639:trends; D006801:Humans; D055624:Methicillin-Resistant Staphylococcus aureus; D012107:Research Design / Q000592:standards* / Q000639:trends; D013203:Staphylococcal Infections / Q000188:drug therapy*
D000900:Anti-Bacterial Agents