In Australia, 13 patients with severe Staphylococcus aureus infection, including infective endocarditis and septic shock, received* intravenous injections of high-quality bacteriophage preparations (manufactured in a GMP-certified facility) as part of a treatment regimen. AB-SA01 was administered twice daily for 14 days, and the patients' clinical, hematological, and biochemical parameters were monitored for 90 days from the start of therapy.

The trial assessed the safety and tolerability of phage therapy, specifically recording symptoms such as pain and redness at the injection site, as well as systemic side effects such as fever, tachycardia, hypotension, diarrhea or abdominal pain, and renal or hepatic impairment. No adverse reactions to bacteriophage administration were observed during the 90-day observation period. This demonstrates the safety of intravenous administration of the AB-SA01 phage preparation in patients with severe AB-SA01 infection.

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A study of the pharmacokinetics of bacteriophages showed that the administration of the phage preparation every 12 hours at a dose of 10 ⁹ CFU is entirely justified - such a scheme can be used in further clinical trials of the phage preparation aimed at studying its effectiveness.

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