Skip to main content
Ir a la página de inicio de la Comisión Europea (se abrirá en una nueva ventana)
español es
CORDIS - Resultados de investigaciones de la UE
CORDIS

A multicenter, double-blind Phase I/II trial evaluating safety and efficacy of a fixed phage cocktail vs. placebo + DAIR in treating S. aureus prosthetic joint infections.

Objetivo

PHAGE4DAIR: Phage therapy for Arthroplasty infections using Local and Conservative surgery (DAIR)

PHAGE4DAIR is a multicenter, randomized, double-blind, placebo-controlled, adaptive Phase I/II clinical trial evaluating the safety and preliminary efficacy of a GMP-manufactured 5-phage cocktail targeting Staphylococcus aureus in prosthetic joint infections (PJI) treated using DAIR (Debridement, Antibiotics, and Implant Retention). Acute S. aureus PJI represents approximately 23% of prosthetic hip and knee infections, with DAIR performed in over 40% of acute cases . Despite its conservative advantages, DAIR is associated with high failure rates, especially in antibiotic-resistant infections, underscoring the urgent need for novel adjunctive therapeutics.

This Horizon Europe trial integrates a seamless Bayesian adaptive design to evaluate dose, route, and treatment efficacy over time. The investigational phage cocktail is already under IND in the United States for related indications, facilitating transatlantic regulatory alignment. Patients will be enrolled based on confirmed S. aureus infection undergoing DAIR, with phages administered intraoperatively and intravenously alongside standard-of-care antibiotics. Co-primary endpoints include safety and clinical cure 3 months post-antibiotic completion.

PHAGE4DAIR will generate high-quality clinical, PK/PD, immunological, and microbiological data to support regulatory decision-making. The consortium includes leaders in GMP manufacturing, clinical trials, and regulatory science. A robust dissemination, exploitation, and regulatory strategy ensures a clear pathway to EMA Scientific Advice, stakeholder engagement, and future Phase III readiness. The project directly supports Horizon Europe’s goal to accelerate phage-based solutions for antimicrobial resistance and foster biotech innovation for difficult-to-treat infections.

Ámbito científico (EuroSciVoc)

Palabras clave

Programa(s)

Tema(s)

Régimen de financiación

HORIZON-RIA - HORIZON Research and Innovation Actions

Ver todos los proyectos financiados en el marco de este régimen de financiación

Convocatoria de propuestas

(se abrirá en una nueva ventana) HORIZON-HLTH-2025-01

Ver todos los proyectos financiados en el marco de esta convocatoria

Coordinador

QEEN BIOTECHNOLOGIES INC.
Aportación neta de la UEn
€ 4 374 508,37
Dirección
669 Auguste-Mondoux, Local 1
J9J 3K3 Gatineau
Canadá
Pyme
Sí
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Enlaces
Coste total
Sin datos

Participantes (20)

Socios (4)