Clinical Trials of Bacteriophage Therapeutics

Abstract

The 100-year anniversary of the discovery of bacteriophages has come and gone. After being overshadowed by the limelight success of penicillin in the 1940s, phage therapy (PT) is once again making headlines in the wake of the antibiotic resistance crisis for its potential to cure bacterial infections. However, the decade-old adage of "the revival of phage therapy" will soon regress to the status of cliché: few clinical trials have been reported in the recent history; and zero Phase III trials exist to date. At such a rate, antibiotic resistance will outpace the exploration and development of PT and its adoption into modern medicine. The medical and scientific communities are now trying to address the enduring uncertainty about PT and recommence clinical evaluation. These phage trials conducted in more recent history, and their germane contributions, as well as valuable lessons, to the establishment of phage therapy as a Western practice, are outlined in this chapter in detail. This chapter aims to explain what phage therapy must confront and accomplish in order to insert itself into contemporary legislative frameworks and contend with the performance of standard pharmaceuticals in clinical trials so that it may be regarded as a viable treatment option beyond niche, noncommercial applications.