McCallin Shawna, Drulis-Kawa Zuzanna, Ferry Tristan, Pirnay Jean-Paul, Nir-Paz Ran
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; ESGNTA - ESCMID study group for non-traditional antibacterials, Basel, Switzerland.
ESGNTA - ESCMID study group for non-traditional antibacterials, Basel, Switzerland; Department of Pathogen Biology and Immunology, University of Wroclaw, Wroclaw, Poland.
Clin Microbiol Infect. 2025 Jun;31(6):910-921. doi: 10.1016/j.cmi.2023.10.018. Epub 2023 Oct 20.
Persistent and resistant infections caused by bacteria are increasing in numbers and pose a treatment challenge to the medical community and public health. However, solutions with new agents that will enable effective treatment are lacking or delayed by complex development and authorizations. Bacteriophages are known as a possible solution for invasive infections for decades but were seldom used in the Western world.
To provide an overview of the current status and emerging use of bacteriophage therapy and phage-based products, as well as touch on the socioeconomic and regulatory issues surrounding their development.
Peer-reviewed articles and authors' first-hand experience.
Although phage therapy is making a comeback since its early discovery, there are many hurdles to its current use. The lack of appropriate standardized bacterial susceptibility testing; lack of a simple business model and authorization for the need of many phages to treat a single species infection; and the lack of knowledge on predictable outcome measures are just a few examples. In this review, we explore the possible routes for phage use, either based on local specialty centres or by industry; the current status of phage therapy, which is mainly based on single-centre or single-bacterial cohorts, and emerging clinical trials; local country-level frameworks for phage utilization even without full authorization; and the use of phage-derived products as alternatives to antibiotics. We also explore what may be the current indications based on the possible availability of phages.
Although phages are emerging as a potential treatment for non-resolving and life-threatening infections, the models for their use and production still need to be defined by the medical community, regulatory bodies, and industry. Bacteriophages may have a great potential for infection treatment but many aspects still need to be defined before their routine use in the clinic.
由细菌引起的持续性和耐药性感染数量不断增加,给医学界和公共卫生带来了治疗挑战。然而,能够实现有效治疗的新型药物解决方案匮乏,或者因复杂的研发和审批流程而延迟。几十年来,噬菌体一直被认为是侵袭性感染的一种可能解决方案,但在西方世界很少使用。
概述噬菌体疗法和基于噬菌体的产品的现状及新用途,并探讨围绕其开发的社会经济和监管问题。
同行评审文章和作者的第一手经验。
尽管噬菌体疗法自早期发现以来正在卷土重来,但其目前的应用仍存在许多障碍。缺乏适当的标准化细菌药敏试验;缺乏简单的商业模式以及因治疗单一物种感染需要多种噬菌体而导致的审批问题;以及对可预测结果指标缺乏了解等,仅举几例。在本综述中,我们探讨了噬菌体使用的可能途径,无论是基于当地的专业中心还是由行业推动;噬菌体疗法的现状,其主要基于单中心或单一细菌队列研究以及正在进行的临床试验;即使没有完全获批,各国当地关于噬菌体利用的框架;以及使用噬菌体衍生产品替代抗生素的情况。我们还根据噬菌体的可能可得性探讨了目前可能的适应症。
尽管噬菌体正成为治疗难治性和危及生命感染的一种潜在疗法,但其使用和生产模式仍需医学界、监管机构和行业来确定。噬菌体在感染治疗方面可能具有巨大潜力,但在临床常规使用之前,许多方面仍需明确。