TY - JOUR
T1 - Considerations for the Use of Phage Therapy in Clinical Practice
AU - Suh, Gina A.
AU - Lodise, Thomas P.
AU - Tamma, Pranita D.
AU - Knisely, Jane M.
AU - Alexander, Jose
AU - Aslam, Saima
AU - Barton, Karen D.
AU - Bizzell, Erica
AU - Totten, Katherine M.C.
AU - Campbell, Joseph L.
AU - Chan, Benjamin K.
AU - Cunningham, Scott A.
AU - Goodman, Katherine E.
AU - Greenwood-Quaintance, Kerryl E.
AU - Harris, Anthony D.
AU - Hesse, Shayla
AU - Maresso, Anthony
AU - Nussenblatt, Veronique
AU - Pride, David
AU - Rybak, Michael J.
AU - Sund, Zoe
AU - Van Duin, David
AU - Van Tyne, Daria
AU - Patel, Robin
N1 - Funding Information:
Preparation of this document was funded in part by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number UM1 AI104681.
Funding Information:
In late 2020, the National Institute of Allergy and Infectious Diseases (NIAID) and the Antibacterial Resistance Leadership Group (ARLG), funded by NIAID, convened a task force comprised of experts in the field of phage therapy, clinical microbiology, antimicrobial resistance, and pharmacology who worked with regulatory experts and a funding agency to develop a series of questions addressing issues surrounding experimental use of phage therapy in clinical practice. These recommendations are not the positions of the National Institutes of Health (NIH) or NIAID; however, several NIAID scientists with expertise in phage therapy contributed to this work. A review of the literature was conducted and each question answered, with gaps in knowledge identified, where applicable, by consensus of ARLG Phage Taskforce members. The ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter bau-mannii, Pseudomonas aeruginosa, and Enterobacter species) bacteria alongside resistant Gram-positive bacteria were prioritized to maintain alignment with the primary mission of ARLG. The ARLG Phage Taskforce was divided into three subgroups, clinical, laboratory testing, and pharmacokinetic subgroups, with representation from NIAID staff on each; each subgroup met regularly to identify relevant questions and examine the associated literature. This report is the product of these efforts, offered as a resource to familiarize clinicians with issues surrounding clinical use of phage therapy and provide an evidence-based evaluation of circumstances where this experimental therapy might be considered, acknowledging that at this point, no recommendation can be made to support routine clinical use of phage therapy under any circumstance.
Publisher Copyright:
© 2022 American Society for Microbiology. All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - Increasing antimicrobial resistance and medical device-related infections have led to a renewed interest in phage therapy as an alternative or adjunct to conventional antimicrobials. Expanded access and compassionate use cases have risen exponentially but have varied widely in approach, methodology, and clinical situations in which phage therapy might be considered. Large gaps in knowledge contribute to heterogeneity in approach and lack of consensus in many important clinical areas. The Antibacterial Resistance Leadership Group (ARLG) has convened a panel of experts in phage therapy, clinical microbiology, infectious diseases, and pharmacology, who worked with regulatory experts and a funding agency to identify questions based on a clinical framework and divided them into three themes: potential clinical situations in which phage therapy might be considered, laboratory testing, and pharmacokinetic considerations. Suggestions are provided as answers to a series of questions intended to inform clinicians considering experimental phage therapy for patients in their clinical practices.
AB - Increasing antimicrobial resistance and medical device-related infections have led to a renewed interest in phage therapy as an alternative or adjunct to conventional antimicrobials. Expanded access and compassionate use cases have risen exponentially but have varied widely in approach, methodology, and clinical situations in which phage therapy might be considered. Large gaps in knowledge contribute to heterogeneity in approach and lack of consensus in many important clinical areas. The Antibacterial Resistance Leadership Group (ARLG) has convened a panel of experts in phage therapy, clinical microbiology, infectious diseases, and pharmacology, who worked with regulatory experts and a funding agency to identify questions based on a clinical framework and divided them into three themes: potential clinical situations in which phage therapy might be considered, laboratory testing, and pharmacokinetic considerations. Suggestions are provided as answers to a series of questions intended to inform clinicians considering experimental phage therapy for patients in their clinical practices.
KW - biofilms
KW - phages
KW - Pseudomonas aeruginosa
KW - Staphylococcus aureus
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U2 - 10.1128/aac.02071-21
DO - 10.1128/aac.02071-21
M3 - Article
C2 - 35041506
AN - SCOPUS:85123890422
VL - 66
JO - Antimicrobial Agents and Chemotherapy
JF - Antimicrobial Agents and Chemotherapy
SN - 0066-4804
IS - 3
M1 - e02071-21
ER -