BioCentury
ARTICLE | Politics & Policy

FDA issues guidance on antibiotics for cIAI

September 29, 2012 1:17 AM UTC

FDA issued draft guidance on the development of drugs to treat complicated intra-abdominal infection (cIAI). The agency recommended the use of active-controlled, non-inferiority Phase III trials for patients for whom an effective therapy is already available. In patients who have limited treatment options, such as those who are intolerant to marketed drugs or who have multi-drug resistant infections, FDA recommended a superiority trial that compares the investigational product to standard of care.

The agency recommended a primary endpoint of clinical success, defined as complete resolution of cIAI symptoms 28 days after treatment start, and absence of clinical failure at 28 days. The agency said secondary endpoints could include an evaluation of time to resolution of symptoms, and the response in various subgroups. ...