Active Infection & Immunity Cancer

Phase 2 Clinical Trial of New Antimicrobial for AMR

Funder Wellcome Charity-funded
Associated organisations National University of Singapore · University of Malaya Europe PMC affiliations are not treated as award recipients or mapped locations.
Funding £12.9M
Period May 2024 — Nov 2027

In plain English

AI plain-English summary

Almost 5 million people die each year from infections that no longer respond to existing drugs, with nearly half of those deaths in Asia. A clinical trials network called ADVANCE-ID, which already recruits over 80 patients per week across more than 50 Asian sites, is preparing to run a Phase II trial of a new antimicrobial developed by an industry partner. The problem is that most antimicrobial trials have relied on sites in Eastern Europe, particularly Ukraine and Russia, leaving Asia—where the burden of antimicrobial resistance (AMR) is highest—underrepresented in drug development. ADVANCE-ID’s existing infrastructure, including an ongoing Phase IV trial supported by Pfizer and bioMerieux, makes it feasible to test new drugs where they are most needed. If this trial succeeds, it could shift the geography of antimicrobial testing, ensuring that new treatments are evaluated in the populations that need them most. That would mean faster access to effective drugs for patients in Asian hospitals, and a more resilient global pipeline against AMR—a system that quietly keeps modern medicine from unravelling.

View original technical description
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.

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Researchers

David Paterson (EPMC Awardee)Helmi Sulaiman (EPMC Awardee)Li Yang Hsu (EPMC Awardee)Yin Mo (EPMC Awardee)

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Original classification

Discretionary Award

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