NCT05369104: PhagoDAIRI

Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.

Status unknown Phase 2 Last updated 22 June 2022

What this trial tests

Phase 2 trial testing Anti-Staphylococcus aureus Bacteriophages in Infection of Total Hip Joint Prosthesis in 64 participants. Status unknown.

Timeline

15 June 2022

Primary endpoint
16 December 2023

16 June 2025

Quick facts

Lead sponsor	Phagenix
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	15 June 2022
Primary completion	16 December 2023
Estimated completion	16 June 2025
Sites	1 location across France

Drugs / interventions tested

• Anti-Staphylococcus aureus Bacteriophages — full drug profile →

Conditions studied

• Infection of Total Hip Joint Prosthesis — all drugs for Infection of Total Hip Joint Prosthesis →
• Infection of Total Knee Joint Prosthesis — all drugs for Infection of Total Knee Joint Prosthesis →

Sponsor

Phagenix — full company profile →

Who can join

18 and older, any sex, with Infection of Total Hip Joint Prosthesis or Infection of Total Knee Joint Prosthesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulations of phage therapy across the world.
   Yang Q, Le S, Zhu T, Wu N. · · 2023 · cited 86× · PMID 37869667 · DOI 10.3389/fmicb.2023.1250848
2. Phage Therapy in Germany-Update 2023.
   Willy C, Bugert JJ, Classen AY, Deng L, et al · · 2023 · cited 29× · PMID 36851802 · DOI 10.3390/v15020588
3. Phage and Endolysin Therapy Against Antibiotics Resistant Bacteria: From Bench to Bedside.
   Taati Moghadam M, Mohebi S, Sheikhi R, Hasannejad-Bibalan M, et al · · 2025 · cited 4× · PMID 40661138 · DOI 10.1002/mco2.70280
4. Advancing the management of prosthetic joint infections: a review of randomized controlled trials and emerging evidence.
   Isler B, Welyczko Z, Jorgensen N, Davis J, et al · · 2025 · cited 1× · PMID 40810728 · DOI 10.1128/aac.00338-25
5. [Bacteriophages for the treatment of musculoskeletal infections-An overview of clinical use, open questions, and legal framework].
   Rupp M, Ferry T, Khan Mirzaei M, Alt V, et al · · 2025 · cited 1× · PMID 40745494 · DOI 10.1007/s00132-025-04690-z
6. [Potential of bacteriophage therapy in Germany: evidence and clinical relevance].
   Bröcker F, Willy C. · · 2025 · cited 1× · PMID 40293490 · DOI 10.1007/s00103-025-04048-y
7. Antimicrobial Resistance: The Answers.
   Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
8. Phage therapy in revision arthroplasty: State of the art and application protocols.
   Wolfgart JM, Schenker H, Gatz M, Migliorini F, et al · · 2026 · PMID 41530815 · DOI 10.1186/s42836-025-00355-6