Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection (PHAGE-MOM-001)

University of Calgary

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Prosthetic Joint Infections of Hip

Treatments: Biological: phage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06814756

REB25-0157

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of active chronic prosthetic joint infection
• Causative bacteria is susceptible to bacteriophage therapy in vitro
• History of multiple failed antibiotic and surgical interventions

Exclusion criteria

• Stage 5 chronic kidney disease
• Cirrhosis
• A known allergy to phage products
• Fever
• Involvement in another clinical trial
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Open Label Arm

Experimental group

Description:

Bacteriophage drug product

Treatment:

Biological: phage therapy