Study on the Safety of Bacteriophage Therapy in Severe Staphylococcus aureus Infection

In this non-comparative study, 13 patients in an Australian hospital with severe Staphylococcus aureus infections received intravenous administration of a good manufacturing practice-quality preparation of three Myoviridae bacteriophages (AB-SA01) as adjunctive therapy. AB-SA01 was administered intravenously twice daily for 14 days, and the recipients’ clinical, hematological, and blood biochemical parameters were monitored for 90 days. The primary outcome was the assessment of safety and tolerability (i.e., pain and redness at the infusion site and systemic adverse effects such as fever, tachycardia, hypotension, diarrhea or abdominal pain, and the development of renal or hepatic dysfunction).

No adverse effects were reported, and our data demonstrate that AB-SA01, administered in this manner, is safe in severe S. aureus infections, including infective endocarditis and septic shock. Future controlled studies will be required to determine the efficacy of AB-SA01, but no phage resistance developed in vivo, and measurements of bacterial and phage kinetics in blood samples suggest that 12-hour dosing of 10⁹ plaque-forming units could provide a rational basis for further studies.

Translation of source: https://www.nature.com/articles/s41564-019-0634-z

Petrovic Fabijan, A., Lin, R.C.Y., Ho, J. et al. Safety of bacteriophage therapy in severe Staphylococcus aureus infection. Nat Microbiol 5, 465–472 (2020). https://doi.org/10.1038/s41564-019-0634-z