Sunday, 22 June 2014

FDA Guidance: Hospital-Acquired Bacterial Pneumonia and Ventilator

The FDA has issued a new guidance document of interest to those working in healthcare. It is titled “Guidance for Industry Hospital-Acquired Bacterial Pneumonia and Ventilator- Associated Bacterial Pneumonia: Developing Drugs for Treatment.”

The introduction to the document reads:

“The purpose of this guidance is to assist sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP).2 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of HABP and VABP. This draft guidance is intended to serve as a focus for continued discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.

This guidance was prepared with the general understanding that a noninferiority trial design evaluating patients who have HABP/VABP would be used to demonstrate effectiveness. This guidance revises the draft guidance for industry Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment issued in November 2010. This guidance includes revisions to the primary efficacy endpoints, the enrollment criteria, the suggested primary efficacy analysis populations, and the noninferiority margin justification.”

To access the document, go to FDA

Thanks to Brian Matthews for the information.

Posted by Tim Sandle