Objective
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine surgery
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs antibiotics
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Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.4 - Infectious Diseases, including poverty-related and neglected diseases
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Topic(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-RIA - HORIZON Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-HLTH-2025-01
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
J9J 3K3 Gatineau
Canada
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Participants (20)
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69002 Lyon
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06003 Nice
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10117 Berlin
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546 36 THESSALONIKI
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WC1E 6BT London
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NW1 2PG London
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HA7 4LP Stanmore
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CB2 0QQ Cambridge
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9713 GZ Groningen
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T2N 1N4 Calgary Alberta
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K1Y 4E9 Ottawa Ontario
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55905 Rochester
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69622 Villeurbanne Cedex
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TS10 4RF REDCAR CLEVELAND
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
M5B 1W8 Toronto
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EX4 4QJ Exeter
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1090 Wien
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B15 2PR Birmingham
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T5J 4P6 Edmonton
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CB6 3NX ELY
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Partners (4)
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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WC2A 3PE London
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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6176 Innsbruck
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
H3Z 2Z3 Westmount
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
34752 Istanbul
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