Abstract
There is a current unmet medical need for the treatment of antibiotic-resistant infections, and in the absence of approved alternatives, some clinicians are turning to empirical ones, such as phage therapy, for compassionate treatment. Phage therapy is ideal for compassionate use due to its long-standing historical use and publications, apparent lack of adverse effects, and solid support by fundamental research. Increased media coverage and peer-reviewed articles have given rise to a more widespread familiarity with its therapeutic potential. However, compassionate phage therapy (cPT) remains limited to a small number of experimental treatment centers or associated with individual physicians and researchers. It is possible, with the creation of guidelines and a greater central coordination, that cPT could reach more of those in need, starting by increasing the availability of phages. Subsequent steps, particularly production and purification, are difficult to scale, and treatment paradigms stand highly variable between cases, or are frequently not reported. This article serves both to synopsize cPT publications to date and to discuss currently available phage sources for cPT. As the antibiotic resistance crisis continues to grow and the future of phage therapy clinical trials remains undetermined, cPT represents a possibility for bridging the gap between current treatment failures and future approved alternatives. Streamlining the process of cPT will help to ensure high quality, therapeutically-beneficial, and safe treatment.
Highlights
The first documented therapeutic case of harnessing the natural antibacterial mechanism of bacteriophages, or phages, for the treatment of a human bacterial infection predates the discovery of antibiotics by two decades [1]
As a result of historical clinical trials and experience accrued during the twentieth century, phages exist alongside antibiotics as approved medicines in some former Soviet Union countries
Traditional drug development pipelines estimate four to ten years for widespread marketing and distribution of any new medicine or therapy, leaving approved phage products something for the future. This substantial lag time between current need and the earliest foreseeable approvals for new antibacterials leaves a considerable number of patients in a highly precarious situation: Reports estimate that approximately 700,000 deaths are caused by antibiotic resistance each year already [74], and claim an even higher number of disability-adjusted life-years and financial burden [75]
Summary
The first documented therapeutic case of harnessing the natural antibacterial mechanism of bacteriophages, or phages, for the treatment of a human bacterial infection predates the discovery of antibiotics by two decades [1]. Phages were used experimentally for the treatment of various bacterial infections throughout the 1920s, including cholera (reviewed in [2]), dysentery [3], and staphylococcal infections [4] to varying degrees of success [5,6]. For these early applications, phages needed to be isolated from environmental sources, cultivated on bacterial hosts, and purified in line with technology at the time. As a result of historical clinical trials and experience accrued during the twentieth century, phages exist alongside antibiotics as approved medicines in some former Soviet Union countries. Several competency centers, physicians, and researchers are invoking phage therapy for compassionate means in order to respond to the current clinical needs of patients suffering from antibiotic failure
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