P-PEAKS UTI

P-PEAKS UTI is a multicenter, intercontinental Phase II randomized controlled trial evaluating the safety, efficacy, and feasibility of personalized bacteriophage therapy in combination with intravenous beta-lactam antibiotics for the secondary prevention of recurrent urinary tract infections (rUTIs) caused by Escherichia coli in female patients . The study will recruit 216 participants across 9 clinical sites, including high-risk renal transplant recipients. Phage therapy or placebo will be administered via oral (day 1 and 2), bladder instillation (day 1), and topical/vaginal routes all over 5 days. Both arms will receive a single dose of IV antibiotic on day 2 to enhance bacterial clearance and biofilm disruption. This combination strategy leverages potential synergy between phages and antibiotics, aiming to reduce recurrence rates and antibiotic use. The project integrates AI-based phage-host prediction, GMP and Magistral phage production, and standardized susceptibility testing aligned with EUCAST guidelines. It investigates phage immunogenicity, microbiome dynamics, and pharmacokinetics/pharmacodynamics to inform future personalized antimicrobial strategies. P-PEAKS UTI also performs health economic analysis to quantify cost-effectiveness of phage therapy in urinary tract infections compared to standard antibiotic treatment and engages patients to address stigma and acceptability of phage therapy. It contributes to regulatory science by generating quantifiable, replicable data to support future market authorization of phage therapies and informs policy through collaboration with EMA and national agencies. In the longer term, we aim to deliver an improved, effective and meaningful solution for the prevention of recurrent UTIs in female patients improving their health outcomes and quality of life. This will also strengthen healthcare systems’ capacity to combat antimicrobial resistance and empower citizens with knowledge-based alternatives to antibiotics.