Clinical work on compounds to
treat community-acquired bacterial pneumonia and hospital-acquired or
ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA
began reassessing its requirements for clinical trial designs, which many
companies said asked for impossible studies.
Discussion at two recent
advisory panel meetings on endpoints and admission criteria for such studies
indicate the agency and the clinical community are getting closer to agreement
on CABP but are not yet on the same page on HABP/VABP.