NCT06827041: BPhage

Use of Phage Therapy for Treatment of a Life-Threatening, Multidrug Resistant Staphylococcus Epidermidis Chronic Periprosthetic Joint Infection: an N-of-1 Trial

Active, enrolled Phase 1 Last updated 12 February 2025

What this trial tests

Phase 1 trial testing Phage (Cytophage Technologies) in Periprosthetic Joint Infection in 1 participant. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 February 2024

Primary endpoint
1 February 2025

1 February 2025

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	22 February 2024
Primary completion	1 February 2025
Estimated completion	1 February 2025
Sites	1 location across Canada

Drugs / interventions tested

• Phage (Cytophage Technologies) — full drug profile →

Conditions studied

• Periprosthetic Joint Infection — all drugs for Periprosthetic Joint Infection →

Sponsor

Ottawa Hospital Research Institute

Who can join

18 and older, any sex, with Periprosthetic Joint Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety of phage therapy
  Time frame: From first day to 12 months from treatment
  Reactions and adverse events to study treatment.
• Efficacy of phage therapy (clinical response)
  Time frame: 1 year
  Wound healing and no recurrence of the infection as determined by the orthopedic infectious diseases physician during follow-up to 12 months from phage treatment.

Sponsor's own description

The goal of this clinical trial is to learn about the safety, tolerability and activity or efficacy of systemic intravenous and intraarticular administration of a mono-bacteriophage (phage) peparation in a patient with chronic-recalcitrant methicillin-resistant Staphylococcus epidermidis (MRSE) periprosthetic joint infection (PJI) and also to understand clinical changes pre- and post-therapy, as well as identifying adjunctive changes in biomarkers (C-reactive protein \[CRP\], erythrocyte sedimentation rate \[ESR\], and interleukin-6 \[IL-6\]) correlated with PJI.

Phage will be administered to the study participant with chronic PJI twice daily over a total duration of two weeks via two routes: a) intravenous (through vein) and b) intra-articular (through the affected joint). Phage therapy is given 4 hours after the patient receives their standard of care antibiotic therapy. The patient will remain in clinical follow-up for up to a year.1

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bacteriophage Therapy: Current Strategies and Future Perspectives.
   Zhou Z, Fu H, Li M, Han Z, et al · · 2026 · PMID 41777249 · DOI 10.1002/mco2.70645
2. Antimicrobial Resistance: The Answers.
   Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
3. Is a Bacteriophage Approach for Musculoskeletal Infection Management an Alternative to Conventional Therapy?
   Eschweiler J, Fischer C, Migliorini F, Greven J, et al · · 2025 · PMID 41157207 · DOI 10.3390/life15101534