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<p>Multidrug-resistant (MDR) pathogens, exemplified by&#xa0;<i>Klebsiella pneumoniae</i>, pose a critical and escalating threat in low- and middle-income countries (LMICs), where limited diagnostic and therapeutic options exacerbate mortality. Bacteriophage (phage) therapy has re-emerged as a promising alternative, offering high specificity, biofilm disruption, and potential for low-cost production. However, a significant translational gap persists; while in vitro studies and results personalized phage therapy demonstrate efficacy, the pathway to clinical integration, especially in LMICs, remains obstructed by systemic barriers including the lack of local phage banks and undefined regulatory pathways. This review moves beyond a summary of biological promise to&#xa0;propose a novel, structured framework for implementation&#xa0;tailored to resource-limited health systems. We synthesize current evidence to introduce the&#xa0;5-P roadmap, a cohesive strategy encompassing the establishment of integrated&#xa0;phage–host biobanks; development of context-appropriate&#xa0;preparations; rigorous&#xa0;preclinical validation emphasizing phage–antibiotic synergy; the parallel development of&#xa0;policy and regulatory pathways; and&#xa0;pilot clinical trials designed for subsequent health system integration. By addressing these interconnected pillars simultaneously, this framework provides an actionable blueprint to advance phage therapy from a laboratory concept to a scalable, equitable, and sustainable adjunct within national antimicrobial resistance strategies in LMICs.</p>

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Reimagining Phage Therapy for MDR Pathogens: From Biobanks to Health System Integration—A Review

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月7日

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  • Abay A. Ayele,
  • Wenfeng Liu,
  • Minfeng Xiao,
  • Alem A. Kalayu,
  • Woldaregay E. Abegaz,
  • Abel A. Negash

摘要

Multidrug-resistant (MDR) pathogens, exemplified by Klebsiella pneumoniae, pose a critical and escalating threat in low- and middle-income countries (LMICs), where limited diagnostic and therapeutic options exacerbate mortality. Bacteriophage (phage) therapy has re-emerged as a promising alternative, offering high specificity, biofilm disruption, and potential for low-cost production. However, a significant translational gap persists; while in vitro studies and results personalized phage therapy demonstrate efficacy, the pathway to clinical integration, especially in LMICs, remains obstructed by systemic barriers including the lack of local phage banks and undefined regulatory pathways. This review moves beyond a summary of biological promise to propose a novel, structured framework for implementation tailored to resource-limited health systems. We synthesize current evidence to introduce the 5-P roadmap, a cohesive strategy encompassing the establishment of integrated phage–host biobanks; development of context-appropriate preparations; rigorous preclinical validation emphasizing phage–antibiotic synergy; the parallel development of policy and regulatory pathways; and pilot clinical trials designed for subsequent health system integration. By addressing these interconnected pillars simultaneously, this framework provides an actionable blueprint to advance phage therapy from a laboratory concept to a scalable, equitable, and sustainable adjunct within national antimicrobial resistance strategies in LMICs.