Abstract
The history of phage therapy started with its first clinical application in 1919 and continues its development to this day. Phages continue to lack any market approval in Western medicine as a recognized drug, but are increasingly used as an experimental therapy for the compassionate treatment of patients experiencing antibiotic failure. The few formal experimental phage clinical trials that have been completed to date have produced inconclusive results on the efficacy of phage therapy, which contradicts the many successful treatment outcomes observed in historical accounts and recent individual case reports. It would therefore be wise to identify why such a discordance exists between trials and compassionate use in order to better develop future phage treatment and clinical applications. The multitude of observations reported over the years in the literature constitutes an invaluable experience, and we add to this by presenting a number of cases of patients treated compassionately with phages throughout the past decade with a focus on osteoarticular infections. Additionally, an abundance of scientific literature into phage-related areas is transforming our knowledge base, creating a greater understanding that should be applied for future clinical applications. Due to the increasing number of treatment failures anticipatedfrom the perspective of a possible post-antibiotic era, we believe that the introduction of bacteriophages into the therapeutic arsenal seems a scientifically sound and eminently practicable consideration today as a substitute or adjuvant to antibiotic therapy.
Highlights
In 1917, Félix d’Hérelle observed a phenomenon in stool cultures from convalescent patients with bacillary dysentery [1], which took the form of perfectly round clear areas in the bacterial lawn.He made the assumption that these clear zones were caused by an "invisible microbe" capable of killing bacteria, to which he gave the name bacteriophage
Based on a large number of published cases in the years that followed, the interest and use of this new treatment in various infections spread rapidly across the world, reaching nearly every continent [2,3]. This was the situation until the discovery of antibiotics; when faced with their easier use, phage therapy was gradually abandoned in Western countries until it disappeared completely in France with the closure in 1990 of the elast remaining sources of therapeutic bacteriophages from the two Pasteur Institutes (Paris and Lyon)
While case reports and historical accounts do not substitute for formal clinical trials, the findings and remarks they contain are useful to set up modern therapeutic protocols and hopefully to avoid conducting additional therapeutically-futile clinical trials. This is what we propose to report here, both by summarizing findings from the literature and by adding our own experience of cases, for osteoarticular infections, treated under compassionate protocols, as a means to advise on the progression of phage therapy into modern medicine
Summary
In 1917, Félix d’Hérelle observed a phenomenon in stool cultures from convalescent patients with bacillary dysentery [1], which took the form of perfectly round clear areas in the bacterial lawn. Phages are considered active pharmaceutical ingredients (APIs) that must be produced according to an internal monograph (set of instructions) and that are subsequently certified by competent laboratories before they are mixed or put into formulation under the supervision of a pharmacist and delivered to a specific patient While this was the first American patient with a systemic MDR infection to be successfully treated intravenous (iv) by phage therapy, more than five patients have been treated since under the FDAs compassionate use program and IPATH is planning to conduct clinical trials in the near future
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