A randomized, placebo controlled, double blind clinical trial of therapeutic bacteriophage preparation in chronic antibiotic-resistant wound infections.

This study is a single-centered, prospective, randomized, double-blind, parallel-group trial of a customized bacteriophage therapy versus the current standard of care dressings of chronic ulcers comparing the safety and efficacy of bacteriophage preparation. Bacteriophage colloquially referred to as ‘phages’ are bacterial viruses have emerged as a most promising alternative therapeutic agent due to its high target specificity, abundance, and lack of effective antibiotics against increasingly resistant pathogens. We have already demonstrated the successful cure of infection and complete healing of chronic wound in two prospective explorative studies by applying customized phages topically and results were encouraging, considering that all the medicated patients were suffering from wound infections that were untreatable using common antibiotics. Clinical trials are necessary for demonstrating that safety and efficacy data generated in a preclinical laboratory environment are translated reliably into clinical practice. This study is undertaken with an aim to treat individuals on a compassionate basis who will have exhausted all other treatment options which will be proved as a progressive approach in the regulated implementation of personalized bacteriophage therapeutics.