FDA has issued draft guidance on drug development for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). FDA offers guidance on the overall development program and clinical trial designs for drugs to support an indication for treatment of HABP and VABP. According to FDA, the draft guidance was “prepared with the general understanding that a noninferiority trial design evaluating patients who have HABP/VABP would be used to demonstrate effectiveness.”
The new draft guidance is a revision of the November 2010 guidance Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment, including changes to the primary efficacy endpoints, the enrollment criteria, the suggested primary efficacy analysis populations, and the noninferiority margin justification. The draft guidance, however, does not discuss statistical analysis or clinical trial design.