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Recommendations and considerations for bacteriophage therapy usage in clinical settings

Phage therapy holds great promise as a new therapeutic option in the face of increasing antimicrobial resistance, but sound clinical data remains a stumbling block to its application. Here, Snehit Satish Mhatre from Eurofins Biopharma Product Testing outlines key considerations to address when designing clinical trials.

The rise in antimicrobial resistance,1 lack of significant antimicrobial discovery in recent years, and increasing instances of multidrug-resistant (MDR) microorganisms2 have propelled the interest in bacteriophage (Phage) therapy as a potential new course of treatment. Patients with implantable devices are more prone to biofilm-mediated infections,3 while other infections such as skin structure infections, chronic lung diseases resulting from respiratory infections, and urinary tract infections (UTIs) can have reoccurrences despite antibiotic treatments.

Over the years, phage therapy has consistently evolved and been subjected to multiple clinical trials.4,5 Phages selectively eliminate the target bacterial host population with no impact on human cells and a much smaller impact on the host commensal bacterial population, which otherwise would be affected by antibiotics. However, one of the most significant challenges concerning phage therapy is the regulations surrounding its clinical usage…