Monday, March 19, 2012
Two companies developing drugs
to treat complicated urinary tract infections say it is feasible to conduct
trials according to recommendations in FDA's new draft guidance. But
clinicians are concerned the results of such studies won't be applicable to
real-world clinical practice in the U.S.
A complicated urinary tract
infection (cUTI) is characterized by pyuria and pathogen on culture of urine or
blood, plus a functional or anatomical abnormality of the urinary tract, and is
accompanied by symptoms such as fever, chills and back pain. For a minority of
patients, cUTIs can be life threatening due to the risk of septic shock.