Bacteriophage Therapy for Morganella Morganii Prosthetic Joint Infection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prosthetic Joint Infections of Hip

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Foothills Medical Centre, University of Calgary

Calgary, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phage therapy

Biological

Single anti-Morganella morganii bacteriophage drug product

Primary outcomes

Clinical response to phage therapy as determined by participant's absence of physical symptoms

Time frame: 1 year

Resolution of the infection, indicated by the absence of clinical symptoms such as wound drainage, swelling, erythema, pain, and fever. This will be determined by a questionnaire and monthly assessments by a Infectious Disease physician.

Secondary outcomes

Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events

Time frame: 29 days

The safety outcome focuses on monitoring and documenting any adverse events (both serious and not) or reactions associated with bacteriophage therapy. Key safety measures include observing for immediate allergic reactions during the first dose, conducting regular clinical assessments, and performing routine bloodwork to detect any potential organ damage or unexpected side effects.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

Qeen Biotechnologies

Registry information

Acronym: PHAGE-MOM-001

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 7, 2025
Registry last updated: Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting