Considerations in the design of clinical trials of antibacterial agents for ventilator-associated pneumonia

Ventilator-associated pneumonia (VAP) remains a cause of additional morbidity, mortality and increased healthcare costs in mechanically ventilated patients. The pathogens responsible for VAP are becoming increasingly resistant to currently available antibiotics and new antibacterial agents are required to maintain an effective therapeutic armamentarium. Clinical trials are necessary to evaluate the effectiveness of antibacterial agents. However, VAP occurs in complex critically ill patients, is difficult to diagnose and its resolution is difficult to ascertain. These clinical characteristics must be considered in the design of clinical trials evaluating antibacterial agents in VAP. Failure to do so will make trial completion difficult and may render the data obtained uninterpretable. Herein we discuss the specific elements that are unique to the design of antibiotic trials for VAP.