Phase 2 Clinical Trial of New Antimicrobial for AMR (360G-Wellcome-228166_Z_23_Z)

Antimicrobial resistance (AMR) is a global issue with almost 5 million deaths annually being associated with AMR. Almost half of these deaths occur in Asia. Development of new antimicrobials has typically relied on clinical trial sites in Eastern Europe, especially in The Ukraine and Russia. ADVANCE-ID is a Wellcome supported infectious diseases clinical trials network comprising over 50 sites in Asia. It currently recruits 80+ patients per week into an observational study of ventilator-associated pneumonia and hospital-acquired bloodstream infections. The extent of AMR in these study sites and the experience of ADVANCE-ID leadership and network site investigators makes conduct of Phase II trial of new antimicrobials in the ADVANCE-ID network highly feasible. This is also emphasised by a current large phase IV RCT being conducted by ADVANCE-ID, sponsored by the National University of Singapore, and supported by bioMerieux and Pfizer. This proposal outlines preparatory activities and then conduct of a Phase II trial to be led by ADVANCE-ID with an industry partner (likely one which has received support for pre-clinical development from CARB-X) and with assistance from a CRO. ADVANCE-ID will have a dominant role in protocol preparation, site identification, site training and liaison, medical support and study analysis.