Bacteriophage Clinical Trial for Periprosthetic Joint Infection of Multidrug Resistant Pseudomonas Aeruginosa

Summary

This is a single patient study (SPS) that aims to test the bacteriophage treatment as an experimental treatment on a patient suffering from chronic periprosthetic joint infection (PJI) of the right hip. This patients has been suffering from an infection in the right sided hip arthroplasty with a multidrug resistant (MDR) strain of Pseudomonas aeruginosa bacteria. All treatment options for this type of infection have been exhausted. If this patient remains without treatment then there is a high risk of mortality secondary to sepsis and the only remaining surgical option for this patient is a hind quarter amputation which will be a devastating surgery that will largely affect this patients quality of life. However, a large number of published case series have shown the positive impact of combining bacteriophage therapy with antibiotics to achieve a synergistic antibacterial effect and overcome possible resistance development to clear the infection. Therefore the investigators intend to try the bacteriophage therapy on this patients infected hip in the aim to control the infection and improve the patients quality of life.

Timeline

Start

—

Primary completion

—

Completion

—

Publications

• Background Suh GA, Ferry T, Abdel MP. Phage Therapy as a Novel Therapeutic for the Treatment of Bone and Joint Infections. Clin Infect Dis. 2023 Nov 2;77(Suppl 5):S407-S415. doi: 10.1093/cid/ciad533.
• Background Ferry T, Kolenda C, Briot T, Souche A, Lustig S, Josse J, Batailler C, Pirot F, Medina M, Leboucher G, Laurent F, On Behalf Of The Lyon Bji Study Group, On Behalf Of The PHAGEinLYON Study Group. Past and Future of Phage Therapy and Phage-Derived Proteins in Patients with Bone and Joint Infection. Viruses. 2021 Dec 2;13(12):2414. doi: 10.3390/v13122414.
• Background Gibb BP, Hadjiargyrou M. Bacteriophage therapy for bone and joint infections. Bone Joint J. 2021 Feb;103-B(2):234-244. doi: 10.1302/0301-620X.103B2.BJJ-2020-0452.R2.
• Background Liu D, Van Belleghem JD, de Vries CR, Burgener E, Chen Q, Manasherob R, Aronson JR, Amanatullah DF, Tamma PD, Suh GA. The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. Viruses. 2021 Jun 29;13(7):1268. doi: 10.3390/v13071268.
• Background Hibstu Z, Belew H, Akelew Y, Mengist HM. Phage Therapy: A Different Approach to Fight Bacterial Infections. Biologics. 2022 Oct 6;16:173-186. doi: 10.2147/BTT.S381237. eCollection 2022.
• Background Akanda ZZ, Taha M, Abdelbary H. Current review-The rise of bacteriophage as a unique therapeutic platform in treating peri-prosthetic joint infections. J Orthop Res. 2018 Apr;36(4):1051-1060. doi: 10.1002/jor.23755. Epub 2017 Nov 22.
• Background Suh GA, Lodise TP, Tamma PD, Knisely JM, Alexander J, Aslam S, Barton KD, Bizzell E, Totten KMC, Campbell JL, Chan BK, Cunningham SA, Goodman KE, Greenwood-Quaintance KE, Harris AD, Hesse S, Maresso A, Nussenblatt V, Pride D, Rybak MJ, Sund Z, van Duin D, Van Tyne D, Patel R; Antibacterial Resistance Leadership Group. Considerations for the Use of Phage Therapy in Clinical Practice. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0207121. doi: 10.1128/AAC.02071-21. Epub 2022 Jan 18.
• Background Scheper H, Gerritsen LM, Pijls BG, Van Asten SA, Visser LG, De Boer MGJ. Outcome of Debridement, Antibiotics, and Implant Retention for Staphylococcal Hip and Knee Prosthetic Joint Infections, Focused on Rifampicin Use: A Systematic Review and Meta-Analysis. Open Forum Infect Dis. 2021 Jul 1;8(7):ofab298. doi: 10.1093/ofid/ofab298. eCollection 2021 Jul.
• Background Bourget-Murray J, Tubin N, Bureau A, Morris J, Ann Azad M, Abdelbary H, Grammatopoulos G, Garceau S. Lower Rates of Reoperation Following Partial or Complete Revision Arthroplasty Compared to Debridement, Antibiotics, and Implant Retention for Early Postoperative and Acute Hematogenous Periprosthetic Hip Infection. J Arthroplasty. 2024 Sep;39(9):2346-2351. doi: 10.1016/j.arth.2024.03.054. Epub 2024 Mar 24.
• Background Taha M, Arnaud T, Lightly TJ, Peters D, Wang L, Chen W, Cook BWM, Theriault SS, Abdelbary H. Combining bacteriophage and vancomycin is efficacious against MRSA biofilm-like aggregates formed in synovial fluid. Front Med (Lausanne). 2023 Jun 9;10:1134912. doi: 10.3389/fmed.2023.1134912. eCollection 2023.
• Background Morcos MW, Kooner P, Marsh J, Howard J, Lanting B, Vasarhelyi E. The economic impact of periprosthetic infection in total knee arthroplasty. Can J Surg. 2021 Mar 5;64(2):E144-E148. doi: 10.1503/cjs.012519.
• Background Akindolire J, Morcos MW, Marsh JD, Howard JL, Lanting BA, Vasarhelyi EM. The economic impact of periprosthetic infection in total hip arthroplasty. Can J Surg. 2020 Jan 29;63(1):E52-E56. doi: 10.1503/cjs.004219.
• Background Matar WY, Jafari SM, Restrepo C, Austin M, Purtill JJ, Parvizi J. Preventing infection in total joint arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:36-46. doi: 10.2106/JBJS.J.01046. No abstract available.
• Background Kamath AF, Ong KL, Lau E, Chan V, Vail TP, Rubash HE, Berry DJ, Bozic KJ. Quantifying the Burden of Revision Total Joint Arthroplasty for Periprosthetic Infection. J Arthroplasty. 2015 Sep;30(9):1492-7. doi: 10.1016/j.arth.2015.03.035. Epub 2015 Mar 31.

Drugs

Indications