FDA eases enrollment criteria in new CABP guidance

Clinical trials evaluating products for community-acquired bacterial pneumonia (CABP) can enroll some patients who had previously received treatment with antibiotics, according to new (see BioCentury, Nov. 14, 2011).

The agency also changed its primary endpoint recommendations in the new draft guidance. Previously FDA had recommended an endpoint based on complete resolution of signs and symptoms five to 10 days after treatment, but the agency now recommends a primary endpoint of clinical success three to five days after treatment defined as improvement from baseline in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum and difficulty breathing. FDA said all-cause mortality at 28 days may be used as a primary endpoint, but that sponsors should first discuss it with FDA. ...