Optimized strategies for introducing new antibiotics in healthcare to preserve patient safety and counteract emergence of resistance
( INTRODUCE )

Following intense efforts to revive the dry antibiotic research and development pipeline, a few highly awaited antibiotics with activity against multidrug-resistant bacteria were recently approved. However, the process of bringing new antibiotics to market and introducing them for clinical use remains ill-defined. Inappropriate and superfluous use of the new antibiotics in one location may deny them from other locations where they have not been used. The INTRODUCE project aims to develop a roadmap for the introduction of new antibiotics following their regulatory approval, to coordinate the processes internationally and provide guidance for monitoring of use and resistance development. We will perform a survey mapping current national strategies, from the decision to make the new drugs available to using them in clinical practice. Initiatives to promote rational use of new antibiotics on the national level, identified in a systematic review and the survey, will be investigated to assess their methods, success, failures, barriers and facilitators. Similarly, we will analyze current programs for surveillance of usage and emerging resistance to the new antibiotics. Based on the synthesis of previous experiences, we will create an open-source platform for surveillance that will be shared widely with interested clinicians, institutions and policymakers. Finally, we will develop a roadmap for the introduction of new antibiotics in collaboration with a broad panel of stakeholders, based on data accumulated in the project and applying expert consensus methods.