Meeting the Challenges to Address Superbugs

• Activity Number: 56
• Type: Invited
• Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
• Sponsor: CHANCE
• Author(s): Thomas Fleming*
• Companies: University of Washington

Abstract

Antibiotics provide meaningful effects on morbidity/mortality in settings such as pneumonia. However, multi-drug resistance is emerging, partly due to their extensive use in other clinical settings where clinical benefits are minimal, such as in acute otitis media. While approaches are needed to avoid overuse of antibiotics, we also need scientific designs allowing efficient and reliable evaluation of safety and efficacy of new antibiotics. Clinical trials should be designed to assess effects on well-defined and reliable outcome measures about how a patient feels (e.g., symptoms), functions (e.g., ability to conduct normal activities), or survives. Given the unmet need to effectively manage patients infected with multi-drug resistant organisms, randomized or historically controlled trials are needed evaluating superiority against best available standard of care. There are ethical and scientific concerns with a frequently advocated alternative approach of using non-inferiority (NI) trials, with poorly justified NI margins, conducted in patients who have disease susceptible to the active control antibiotic regimen. Creative approaches also are needed to reduce missing data.