A Phase 1/2 interventional study of Five phage anti-Staphylococcus aureus bacteriophage cocktail in Prosthetic Joint Infections of Hip and Bacteriophage Therapy, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by University of Calgary · Phase 1/2, Interventional, and Treatment
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 Staphylococcus lugdunensis 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.
University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Five phage anti-Staphylococcus aureus bacteriophage cocktail
Biological: Five phage anti-Staphylococcus aureus bacteriophage cocktail
Five phage anti-Staphylococcus aureus bacteriophage cocktail for targeted treatment of a Staphylococcus lugdunensis infection.
Clinical response to phage therapy as determined by participant's absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever.
Resolution of the infection, indicated by the absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever. The infection will be considered to be resolved if these physical clinical symptoms are absent.
Time frame: 1 year
Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events
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.
Time frame: 29 days
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Calgary