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FDA panel continues to review trial designs for bacterial pneumonia
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The FDA’s Anti-Infective Drugs Advisory Committee met this week to discuss clinical trial designs for the development of antibacterials for the treatment of both community-acquired and hospital-acquired bacterial pneumonia.
Panel members reviewed several questions compiled by the FDA based on two draft documents: Guidance for Industry Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment, published in March 2009 and Guidance for Industry, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment, published in November 2010.
Edward Cox, MD, director of the FDA’s Office of Antimicrobial Products, said there is a continued need for new treatments for patients with community-acquired bacterial pneumonia and that prudent use of new and existing antibacterial drugs is essential to preserve utility.
Panel members agreed that use of concomitant antibacterial therapy should be avoided; however, the panel was split regarding receipt of prior antibacterial therapy, as some strongly discouraged use because it’s problematic in noninferiority trials.
Committee members also discussed the merits and limitations of a single trial for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The majority were in favor of a single, well-controlled ventilator-associated bacterial pneumonia trial, as bacterial disease is more likely with ventilator-associated bacterial pneumonia.
“It’s important that we help find a tractable and flexible path forward,” John Rex, MD, acting industry representative and vice president of clinical infection for AstraZeneca in the UK, said during the meeting. “We need to solve it for therapies going into trials today and for therapies going into trials 10 years from now.”