Recommended design features of future clinical trials of antibacterial agents for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

摘要

The efficacy of new antibacterial agents for the treatment of hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) has typically been compared with that of established antibacterial agents in noninferiority clinical trials. However, the US Food and Drug Administration (FDA) has reevaluated the appropriateness of noninferiority trial designs for a variety of diseases, including HAP and VAP. The resulting regulatory uncertainty regarding appropriate trial design is an important barrier to the development of new antibacterial agents.