Prosthetic Joint Infections of Hip
Conditions
Keywords
Bacteriophage, Periprosthetic joint infection, Phage therapy
Brief summary
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.
Interventions
BIOLOGICALphage therapy
Single anti-Morganella morganii bacteriophage drug product
Sponsors
Qeen Biotechnologies
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single patient
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to phage therapy as determined by participant's absence of physical symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events | 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. |
Countries
Canada
Outcome results
None listed