Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator- Associated Pneumonia; Public Workshop

概要

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital- acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). This public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on March 31, 2009, from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available