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 is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a Morganella morganii prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. The treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area and 14 days of intravenous phage therapy. The goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.

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

Collaborator

Trials

1

Recruited

1+