Phage Therapy for Periprosthetic Joint Infection

Overseen By Christiaan Righolt, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Orthopaedic Innovation Centre

Disqualifiers: Below 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

Trial Summary

What is the purpose of this trial?

This purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of a bacteriophage therapy in a patient with a methicillin-susceptible Enterococcus faecium (E. faecium) prosthetic joint infection (PJI) of the hip. We have exhausted all surgical and medical management of PJI for our patient. The phage will be administered to the study patient during a 14 days period via intravenous and intra-articular. The patient will be monitored in clinic for up to 1 year.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Phage Therapy for Periprosthetic Joint Infection?

Research shows that combining phage therapy with antibiotics significantly reduces infection relapse rates in patients with periprosthetic joint infections compared to antibiotics alone. Additionally, studies indicate that phage therapy can effectively reduce bacterial load and inflammation, especially when used alongside antibiotics. ^{1 2 3 4 5}

Is phage therapy safe for treating infections?

Phage therapy has been generally found to be safe in humans, with most studies reporting no serious safety concerns. Some mild, temporary side effects have been noted, often related to impurities in the treatment, but these are not severe. ^{1 6 7 8 9}

How is phage therapy different from other treatments for periprosthetic joint infections?

Phage therapy is unique because it uses viruses called bacteriophages to specifically target and destroy bacteria, including those in protective biofilms that make infections hard to treat. Unlike traditional antibiotics, phages can be personalized to attack specific bacterial strains and can work together with antibiotics to enhance their effectiveness. ^{1 2 4 7 10}

Research Team

David Hedden, MD

Principal Investigator

Concordia Hospital

Eligibility Criteria

This trial is for a patient with a chronic Enterococcus faecium infection in an artificial hip joint, who has not improved after all standard treatments. The person must have this specific type of bacteria and be able to attend follow-up appointments for up to one year.

Inclusion Criteria

Willingness to provide signed and dated informed consent form to participate in the clinical study

I have a long-term infection in my artificial joint.

I've had surgeries and medications that didn't improve my condition.

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Lytic phage therapy administered intravenously and intra-articularly twice daily for 14 days, alongside standard of care antibiotic therapy

2 weeks

Daily visits for administration

Follow-up

Participants are monitored for safety, tolerability, and efficacy of the phage therapy, with clinical changes and biomarker assessments

1 year

Regular clinic visits

Treatment Details

Interventions

• Phage Therapy

Trial Overview The study tests bacteriophage therapy, which uses viruses that target bacteria, given through IV and directly into the joint over two weeks. It aims to see if it's safe and works when other treatments fail.

Participant Groups

Group I: Phage Therapy Experimental Treatment 1 Intervention

Lytic phage prepared in injection-grade saline-magnesium buffer will be given via two routes: a) intravenously twice daily, and concomitantly, b) intra-articularly twice daily, for a total duration of 14 days. In addition to phage therapy, the patient will receive standard of care antibiotic therapy.

Who Is Running the Clinical Trial?

Orthopaedic Innovation Centre

Lead Sponsor

Trials

7

Recruited

670+

Cytophage Technologies Inc.

Collaborator

Trials

1

Recruited

1+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Experience Using Adjuvant Bacteriophage Therapy for the Treatment of 10 Recalcitrant Periprosthetic Joint Infections: A Case Series. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Current review-The rise of bacteriophage as a unique therapeutic platform in treating peri-prosthetic joint infections. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes of Phage-Antibiotic Combination Treatment in Adult Patients with Periprosthetic Hip Joint Infection. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Bacteriophages as Adjuvant to Antibiotics for the Treatment of Periprosthetic Joint Infection Caused by Multidrug-Resistant Pseudomonas aeruginosa. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of bacteriophage as an adjunct therapy for treatment of peri-prosthetic joint infection caused by Staphylococcus aureus. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Phage Therapy for Bone and Joint Infections: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of Staphylococcal Clinical Isolates from Periprosthetic Joint Infections for Potential Bacteriophage Therapy. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The promising role of bacteriophage therapy in managing total hip and knee arthroplasty related periprosthetic joint infection, a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Phage Therapy as a Novel Therapeutic for the Treatment of Bone and Joint Infections. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Combining bacteriophage and vancomycin is efficacious against MRSA biofilm-like aggregates formed in synovial fluid. [2023]