FDA recommends survival endpoint, narrows antibiotic exclusion

FDA continues to recommend all-cause mortality as a potential primary endpoint for clinical trials evaluating products for hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP) in (see BioCentury, Nov. 14, 2011).

FDA also eased restrictions on prior antibiotic use in the enrollment criteria for HABP/VABP trials. The agency now recommends the exclusion of subjects who have received an antibiotic within the last three days. Previously the agency called for the exclusion of subjects who have received an antibiotic within 30 days, a requirement the 2011 panel criticized, as most patients on ventilators are already receiving antibiotics for other conditions. Comments on the draft guidance are due August 5. ...