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

NCT06798168 | Unknown

• 1 other identifier: OLIP1
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 we 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.

Conditions

Joint Infection

Keywords

Phage therapy; Periprosthetic Joint Infection; Bacteriophage

Interventions

Combining bacteriophage therapy with antibiotics for a case with hip PJI BIOLOGICAL

The treatment plan is to treat the patient with weekly intra-articular injections of a personalized phage therapy cocktail (QDP-PSA-011) for 3 consecutive weeks. This will be associated with antibiotics for 6 weeks.

Also known as: bacteriophage intra-articular injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is clinically stable and independently mobile
• Patient has been diagnosed with a multidrug resistant chronic bacterial PJI and has exhausted all other non-debilitating treatment options (including DAIR and antibiotic therapy)

You may not qualify if:

• Patient has cultured multiple bacteria and it is difficult for physicians to determine which bacteria is causing the disease
• Patient develops a life threatening condition or a condition that leads to deterioration of the patients medical condition and that is unrelated to the known PJI as cerebrovascular accident, angina, cancer.
• Patient's clinical condition is no longer stable and deteriorating for example, if the patient develops sepsis secondary to PJI prior to the commencement of the phage therapy.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Canada

AVAILABLE

Related Publications (14)

• 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.

  PMID: 37932115 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.

  PMID: 34960683 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.

  PMID: 33517726 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.

  PMID: 34209836 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.

  PMID: 36225325 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.

  PMID: 28971508 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.

  PMID: 35041506 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.

  PMID: 34258321 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.

  PMID: 38531489 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.

  PMID: 37359001 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.

  PMID: 33666386 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.

  PMID: 31995337 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.

  PMID: 21123590 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.

  PMID: 25865815 BACKGROUND

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Dr. Hesham Abdelbary, MD FRCSC MSc

CONTACT

+(1) 613-737-8899; habdelbary@toh.ca

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CA (1)