Bacteriophage Therapy for Prosthetic Hip Joint Infection

(PHAGE-MOM-001 Trial)

Overseen By Teresa Nguyen

Age: Any Age

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: University of Calgary

Disqualifiers: Stage 5 kidney disease, Cirrhosis, Allergy to phage, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for difficult-to-treat hip joint infections caused by the bacteria Morganella morganii. The treatment uses bacteriophages, viruses that target and destroy bacteria, to clear the infection and prevent recurrence. Participants will receive injections directly into the joint, along with additional therapy through an IV. This trial may suit individuals with chronic hip joint infections unresponsive to other surgeries or antibiotics. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive 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. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that phage therapy could be a promising way to treat infections in artificial joints. In one study, about 78% of patients who received this treatment had their infections cleared, indicating that most patients improved.

While these studies primarily assess the treatment's effectiveness, they also evaluate its safety. Reports suggest that phage therapy is generally safe for patients. Serious side effects are rare, though minor ones, such as reactions at the injection site, can occur.

This trial includes both early and middle stages of research, providing some confidence in the treatment's safety. However, like any treatment, there are always risks, so discussing these with the trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for prosthetic hip joint infections, which often involve antibiotics or surgery, phage therapy uses viruses called bacteriophages to specifically target and destroy bacteria. This unique mechanism of action is exciting because bacteriophages can be highly specific, attacking only the harmful bacteria and leaving beneficial bacteria unharmed. Researchers are also enthusiastic about this approach as it offers a potential solution to antibiotic-resistant infections, a growing concern in medical treatment. By harnessing these natural bacterial predators, phage therapy could offer a more precise and effective alternative to the current standard of care.

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

Research has shown that phage therapy, which participants in this trial will receive, can help treat infections in artificial joints. In one study, about 78% of patients experienced improvement in their infections after receiving phage treatment. This therapy uses special viruses called bacteriophages to attack and kill bacteria, helping to clear infections that resist regular antibiotics. Another study found that combining phage therapy with less invasive surgeries led to successful outcomes in many cases. These findings suggest that phage therapy could be a promising option for hard-to-treat infections like Morganella morganii in artificial joints. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for a patient with a chronic infection in their hip replacement that hasn't improved after many antibiotic treatments and surgeries. The bacteria causing the infection must be vulnerable to bacteriophage therapy when tested outside of the body.

Inclusion Criteria

I have an ongoing infection in my artificial joint.

The bacteria causing my infection can be treated with bacteriophage therapy.

I have had several unsuccessful antibiotic treatments and surgeries.

Exclusion Criteria

A known allergy to phage products

Involvement in another clinical trial

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 2 intra-articular injections of bacteriophages and 14 days of intravenous phage therapy

2 weeks

2 visits (in-person) for injections, daily monitoring for intravenous therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Monthly assessments by an Infectious Disease physician

What Are the Treatments Tested in This Trial?

Interventions

• Phage Therapy

Trial Overview The study tests bacteriophage therapy, which uses viruses that target bacteria, on a single patient with an infected hip joint. It includes two injections directly into the joint and two weeks of intravenous treatment to clear the infection.

How Is the Trial Designed?

Group I: Open Label Arm Experimental Treatment 1 Intervention

Bacteriophage drug product

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Qeen Biotechnologies

Industry Sponsor

Qeen BioTechnologies

Collaborator

Trials

1

Recruited

1+

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 ... This review discusses the current applications of phage therapy in the management of PJI, exploring its underlying mechanisms, clinical outcomes, and practical ...

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. link.springer.com link.springer.com/article/10.1007/s00264-024-06295-1

Bacteriophage therapy as an innovative strategy for the ... The findings revealed that implants containing bacteriophages were effective in both treating and preventing infections caused by methicillin- ...

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

Phage Therapy as a Novel Therapeutic for the Treatment of ... Efficacy with phage therapy was shown here in combination with less invasive surgeries and retention of implants. Of the 19 successful PJI cases ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04787250

Bacteriophage Therapy in Patients With Prosthetic Joint ... This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by 1 or 2 of the ...

7. 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% ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9929010/

The promising role of bacteriophage therapy in managing ... Bacteriophage therapy (BT) was used as an adjuvant for PJI management, aiming at treating resistant infections, decreasing morbidity, and mortality.