REcurrent urinary tract infection: Efficacy and safety of PHage theRapy and Microbiota transfEr (REPhRAME)

Recurrent urinary tract infections (rUTIs) impose a substantial clinical and socio-economic burden, particularly in women, and are increasingly complicated by antimicrobial resistance (AMR). Current treatment options rely heavily on antibiotics, fueling resistance and limiting therapeutic efficacy.

The REPhRAME project addresses this unmet need by evaluating innovative, non-antibiotic strategies: a bacteriophage-based investigational medicinal product for acute treatment, and fecal microbiota transplantation (FMT-IMP) to prevent recurrence.

Building on a seamless Phase Ib/IIa randomized controlled trial, the study will determine optimal routes of administration, assess efficacy in reducing antibiotic use, and evaluate recurrence prevention. Multi-omics analyses, biomarker discovery, and health economic modelling complement the clinical trial, while patient engagement, ethical oversight, and regulatory alignment ensure societal relevance and translational impact.

By integrating precision medicine, novel biologics manufacturing, and robust clinical evidence, REPhRAME aims to pioneer sustainable alternatives to antibiotics, improving quality of life and supporting EU goals in AMR mitigation and healthcare innovation.

Project coordinator

• Johann Wolfgang Goethe-Universitaet Frankfurt am Main, Frankfurt, Germany

Project Partners

• Klinikum der Universitaet zu Koeln, Koeln, Germany
• Universitaet Zurich, Zurich, Switzerland
• Academisch Ziekenhuis Leiden, Leiden, Netherlands
• HUN-REN Szegedi Biologiai Kutatokozpont, Szeged, Hungary
• SIB Swiss Institute of Bioinformatics, Geneve, Switzerland
• Medizinische Hochschule Hannover (MHH), Hannover, Germany
• Jafral, Biotehnoloske Raziskave in Razvoj, Ljubljana, Slovenia
• SNIPR Biome ApS, Copenhagen, Denmark
• Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung EV, Munchen, Germany
• LINQ Management GmbH, Berlin, Germany
• The University of Reading, Reading, United Kingdom
• Universitaet Bern, Bern, Switzerland
• University of Leicester, Leicester, United Kingdom
• Rigas Stradina Universitate, Riga, Latvia
• Deutsches Zentrum fur Infektionsforschung, Braunschweig, Germany