Drug resistant infections currently kill about 700,000 people worldwide; current trends predict resultant deaths spiraling to 10 million annually by 2050. Despite growing interest in the possibilities of bacteriophage as components of a solution and their long history of successful use in some parts of the world, little progress has been made toward clinical trials to encourage phage therapy adoption. Both coliform infant diarrhea and burn wounds infected with Pseudomonas aeruginosa, E. coli and/or Staphylococcus aureus provide promising eventual targets for phage-based therapies, but are complex and varied enough to be very challenging in terms of developing and rapidly implementing successful double-blind clinical trials, as required in the West. Staphylococcus-infected diabetic foot ulcers which have proven recalcitrant to antibiotics are promising for developing protocols permitting quick implementation. Phage treatment also offers a number of special advantages in tackling such chronic ulcer infections. Not only can phage treat antibiotic-resistant infections, but also cases where vascular compromise limits antibiotic effectiveness even when bacteria are sensitive to the antibiotics prescribed.
We here present three representative patients from a compassionate-use series of nine where phage treatment resolved the infections in every case of compromised soft tissue and bone where appropriate antibiotic treatment had failed, thus obviating the need for amputation. Toes were studied as they provide similar wounds equally distant from the central circulation, making them a particularly good subpopulation for randomized study. Our compassionate use of phage in diabetic foot infections demonstrates the effectiveness of phage when regular antibiotic treatment has failed and helped develop evidence based protocols for future randomized trials like that just posted by Pherecydes on ClinicalTrials.gov. Adding metagenomics analyses before and after treatment will help further test the widespread belief among wound physicians that Staphylococcus aureus is the critical “head of the snake” in such infections.