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Safety of bacteriophage therapy in severe Staphylococcus aureus infection

5 March 2020
MBI researchers new publication: Nature Microbiology
There is new optimism for phage therapy, an approach that has been with us for 100 years and is now being embraced anew. A rigorous clinical and biological approach will serve us well and effective partnerships between government, industry and the academy are essential.
Aleksandra Petrovic Fabijan, Ruby C. Y. Lin, Josephine Ho, Susan Maddocks, Nouri L. Ben Zakour, Jonathan R. Iredell & Westmead Bacteriophage Therapy Team

Abstract

In this single-arm non-comparative trial, 13 patients in an Australian hospital with severe Staphylococcus aureus infections were intravenously administered a good manufacturing practice-quality preparation of three Myoviridae bacteriophages (AB-SA01) as adjunctive therapy. AB-SA01 was intravenously administered twice daily for 14 d and the clinical, haematological and blood biochemical parameters of the recipients were monitored for 90 d. The primary outcome was the assessment of safety and tolerability (that is, pain and redness at the infusion site and systemic adverse reactions, such as fever, tachycardia, hypotension, diarrhoea or abdominal pain and the development of renal or hepatic dysfunction). No adverse reactions were reported, and our data indicate that AB-SA01 administered in this way is safe in severe S. aureus infections, including infective endocarditis and septic shock. Future controlled trials will be needed to determine the efficacy of AB-SA01 but no phage resistance evolved in vivo and the measurements of bacterial and phage kinetics in blood samples suggest that 12 h dosing of 109 plaque-forming units may be a rational basis for further studies.

DOI: https://doi.org/10.1038/s41564-019-0634-z

More evidence in support of phage is still needed before it’s offered to patients on a larger scale. However, our study makes it clear that it could, potentially, offer a safe treatment for serious infections, and help reduce the impact of antibiotic resistance
Professor Jon Iredell

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