Tribulations of trials for antibacterial drugs: interview with Joseph Kuti

Author(s): Joseph Kuti

Following draft guidance from the US FDA in March 2009 [1] on trials to assess antibacterial agents for community-acquired bacterial pneumonia, there has been much debate between industry, academia and regulatory bodies on the issues faced in the design of such trials. Follow up workshops and guidance [2,3] have contributed to the active discussion on the topic, highlighting the increasing urgency of bringing effective therapies to market in the wake of increasing strains of multidrug resistant bacteria. Joseph Kuti, Brad Spellberg, Sumati Nambiar and Mark Leuchtenberger and Scott Hopkins all spoke with Laura Harvey at Clinical Investigation on some of the key issues facing clinical trials in this arena. Joseph Kuti sits on the Clinical Investigation editorial board and is the associate director of Clinical and Economic Studies at the Center for Anti-Infective Research and Development at Hartford Hospital, Connecticut and also holds an Adjunct Assistant Professor appointment at the University of Connecticut School of Pharmacy. Kuti’s research interests include the pharmaco-kinetics, -dynamics, -economics and outcomes of antimicrobial therapy in severe infections.