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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called phage therapy to combat infections in individuals with persistent joint infections from hip replacements. The goal is to determine if this therapy is safe and effective when traditional surgeries and medicines have failed. Phage therapy uses viruses to target and destroy bacteria and will be administered alongside standard antibiotics. This trial specifically targets individuals with long-term hip joint infections that have not improved with multiple treatments. As a Phase 1/Phase 2 trial, it aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to benefit from this innovative therapy.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that phage therapy is generally safe. In studies involving 33 cases of bone and joint infections treated with phage therapy, safety was a primary concern. These studies reported no serious side effects, and most patients responded well to the treatment.

Specifically, 78% of patients experienced improvement or remission of their infections. This indicates that the treatment was effective for many patients and did not cause major harm. Although phage therapy remains relatively new, early results suggest it is safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Phage therapy is unique because it uses viruses called bacteriophages to specifically target and destroy bacteria causing periprosthetic joint infections. Unlike standard antibiotics, which can sometimes struggle with resistant bacteria, phages are natural predators of bacteria and can evolve alongside them, potentially reducing resistance issues. Additionally, phage therapy offers a novel delivery method, being administered both intravenously and directly into the joint, which might enhance its effectiveness in tackling stubborn infections. Researchers are excited about this approach because it offers a targeted alternative that could work even when traditional antibiotics fail.

What evidence suggests that phage therapy might be an effective treatment for prosthetic joint infection?

Research has shown that phage therapy could effectively treat infections in artificial joints. Studies found that about 78% of patients experienced a reduction or disappearance of infection symptoms after receiving phage therapy. In some cases, this success rate increased to 83% with longer observation periods. Another study demonstrated an 87% success rate in treating bone and joint infections with phage therapy. This trial will evaluate phage therapy for managing infections in prosthetic joints, especially when other treatments have failed. ^{1 5 6 7 8}

Who Is on the Research Team?

David Hedden, MD

Principal Investigator

Concordia Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11122905/

How Effective Is Phage Therapy for Prosthetic Joint Infections ... A random-effects proportional meta-analysis suggested infection remission in 78% of patients (95% CI: 39%, 95%) (I2 = 55%, p = 0.08) and 83% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189447/

Current Applications and the Future of Phage Therapy for ... The study reported an infection remission rate of 78%, with improved durability of outcomes (83% remission) in patients followed for at least 12 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05269134

Study Details | NCT05269134 | Bacteriophage Therapy in ... This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the ...

4. nature.com nature.com/articles/s41598-025-08759-9

In vitro activity of phages against periprosthetic joint ... Clinical studies have reported 33 bone and joint infection cases treated with phage therapy, where 87% achieved success, with the remaining ...

5. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09814-y

Proportion of patients with prosthetic joint infection eligible for ... The aim of this study was to establish the proportion of patients eligible for phage therapy and to assess their clinical outcome judged against all patients ...

6. academic.oup.com academic.oup.com/cid/article/77/Supplement_5/S407/7334983

Phage Therapy as a Novel Therapeutic for the Treatment of ... Here we examine the safety and efficacy of English-language published cases of BJI since 2010 with phage therapy. From 33 reported cases of BJI ...

7. journals.asm.org journals.asm.org/doi/10.1128/aac.00338-25

Advancing the management of prosthetic joint infections The primary outcome is treatment success at 1 year after completing antimicrobial therapy (15 months after DAIR). Success is defined as the ...

8. mdpi.com mdpi.com/1648-9144/60/5/790

How Effective Is Phage Therapy for Prosthetic Joint ... A random-effects proportional meta-analysis suggested infection remission in 78% of patients (95% CI: 39%, 95%) (I2 = 55%, p = 0.08) and 83% ...