Phage therapy for KPC-producing Klebsiella pneumoniae decolonization in high-risk patients : The KIDNAP Study Protocol – A prospective feasibility and proof of concept study in the Brazilian context

Article Article scientifique Article Phage therapy for KPC-producing Klebsiella pneumoniae decolonization in high-risk patients : The KIDNAP Study Protocol – A prospective feasibility and proof of concept study in the Brazilian context eng 2025-11-20 2026-01 author Najjar Iris Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil. Electronic address: iris.najjar@aphp.fr. 413508 author Gandolpho Larissa Simão Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil; Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Division of Hematology, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil. author Dos Santos Jôiciglecia Pereira Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil. author Siqueira Camila de Paula Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil. author Moses Ikechukwu B Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil; Department of Applied Microbiology, Ebonyi State University, Abakaliki, Ebonyi, Nigeria. author Ribeiro Ághata Cardoso da Silva Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil. author Roch Mélanie 0000-0001-6485-8434 Department of Microbiology and Molecular Medicine, University of Geneva, Geneva, Switzerland; Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals and Medical School, Geneva, Switzerland. 884710 Département de microbiologie et médecine moléculaire (MIMOL) author Sierra Roberto Department of Microbiology and Molecular Medicine, University of Geneva, Geneva, Switzerland; Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals and Medical School, Geneva, Switzerland. 724681 Roberto Mario Sierra Miranda author Andrey Diego Olivier 0000-0003-3247-9274 Department of Microbiology and Molecular Medicine, University of Geneva, Geneva, Switzerland; Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals and Medical School, Geneva, Switzerland; Department of Diagnostics, Geneva University Hospitals and University of Geneva, Geneva, Switzerland. 542856 Département de médecine (DEMED) author Arrais-Rodrigues Celso Division of Hematology, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil. author Gales Ana C Laboratório Alerta, Division of Infectious Diseases, Escola Paulista de Medicina-Universidade Federal de São Paulo, São Paulo, Brazil; Antimicrobial Resistance Institute of São Paulo (ARIES), Universidade Federal de São Paulo, São Paulo, Brazil. 107673 10.1016/j.ijantimicag.2025.107673 41274315 0924-8579 https://www.sciencedirect.com/science/article/pii/S0924857925002286 Background: There has been renewed interest in phages amidst growing antimicrobial resistance. Their potential for intestinal decolonisation is interesting because of their specificity, minimal side effects, and microbiota preservation. In addition, phage-resistant bacterial mutants that arise during treatment may become more susceptible to antibiotics and less virulent, possibly leading to better clinical outcomes. Objectives: This study's primary objective is to measure the efficacy of phage-based intestinal decolonisation of Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae (KPC-Kp) at 14 days post-treatment, as well as its feasibility, which is defined as >80% achieving at least 7 days of treatment. Secondary objectives will include phage safety at 14 days post-treatment, intestinal KPC-Kp load changes over time, characterisation of phage-resistant KPC-Kp mutants, microbiome changes, infection-related outcomes, and general clinical outcomes 3 months after the end of treatment. Methods: This feasibility and proof-of-concept study aims to include 15 high-risk patients recruited from a tertiary hospital in São Paulo who will receive individualised phage combinations for a mean duration of 14 days. Safety data will be reviewed by an independent Safety Monitoring Board. Description of microbiological techniques is provided. Conclusions: To the best of our knowledge, this is the first published protocol that aims to establish a standardised, individualised phage-treatment framework for intestinal decolonisation in a high-endemic setting. It will also explore phage-bacterial interactions and their broader impact on bacterial virulence and susceptibility profiles. It represents a stepping stone towards implementing phage therapy in South America and bringing knowledge and capacities to the countries most impacted by escalating antimicrobial resistance. Anti-Bacterial Agents / therapeutic use Bacterial Proteins / genetics Bacterial Proteins / metabolism Bacteriophages Brazil Feasibility Studies Humans Klebsiella Infections / microbiology Klebsiella Infections / therapy Klebsiella pneumoniae / drug effects Klebsiella pneumoniae / enzymology Klebsiella pneumoniae / virology Phage Therapy / methods Proof of Concept Study Prospective Studies Beta-Lactamases / genetics Beta-Lactamases / metabolism Dewey 616 Swiss National Science Foundation Phages in the fight against antimicrobial resistance : An innovative decolonization strategy for Klebsiella pneumoniae carbapenemase-producing Klebsiella pneumoniae in the endemic Brazilian context 214188 CH 54 Département de microbiologie et médecine moléculaire 21B 56 Département de médecine 221 false 1434 Infections bactériennes multi-résistantes 1060 International journal of antimicrobial agents 67 1 cf765d47-84f6-4f77-bde4-d159789b0e57 Article (Published version) Public 1-s2.0-S0924857925002286-main.pdf 672321 application/pdf OA OTHER cc9a1d9eb07bd83202cd13b8fcdff3eae44829206f8f479f2a2f5c2a4e2a5d51 7feaf0ab-1874-46f6-8529-234f62c9ac93 Erratum Public 1-s2.0-S0924857926000555-main.pdf 223561 application/pdf CC BY-NC-ND-4.0 b36f129d6ab6a42d3e7482975a6195bcaf3dd5ea93bc1d4fdcee99f7c43bcd39 In the “Fundings” section, the FAPESP project number was omitted (CEPID ARIES – FAPESP Process Number: 2021/10599-3), and a spelling error occurred in “Fondation Privée des HUG”. 10.1016/j.ijantimicag.2026.107766 41934050 openAccess Faculté de médecine / Section de médecine fondamentale / Département de microbiologie et médecine moléculaire Faculté de médecine / Section de médecine clinique / Département de médecine

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Phage therapy for KPC-producing Klebsiella pneumoniae decolonization in high-risk patients : The KIDNAP Study Protocol – A prospective feasibility and proof of concept study in the Brazilian context	International journal of antimicrobial agents	2026	1	0
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