REPhRAME (REcurrent urinary tract infection: Efficacy and safety of PHage theRapy and Microbiota transfEr) aims to address the most urgent need in the field of bacteriophage (phage) therapy: generation of high quality clinical data in order to evaluate the clinical efficacy and safety of phage treatment as a weapon against difficult-to-treat and antimicrobial resistant infections for patients suffering in Europe. REPhRAME brings together product developers, manufacturers, clinicians, and scientists and brings an ambitious project to fruition and ultimately deliver sustainable phage therapy to European patients addressing the world-wide crisis of antimicrobial resistance (AMR).
Primary objective of the project is to conduct a seamless Phase Ib/IIa, multicenter, pan-European, multistep randomisation, placebo-controlled clinical trial (RCT) to evaluate the safety and clinical efficacy of oral, intravenous (IV) and intravesical (IVS) i) phage therapy alone, ii) phage therapy combined with antibiotic treatment and iii) phage treatment with a sequential FMT treatment in patients with rUTI.