Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Five phage anti-Staphylococcus aureus bacteriophage cocktail.
- Who it may be relevant to
- Registry conditions: Prosthetic Joint Infections of Hip, Bacteriophage Therapy. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Five phage anti-Staphylococcus aureus bacteriophage cocktail
Five phage anti-Staphylococcus aureus bacteriophage cocktail for targeted treatment of a Staphylococcus lugdunensis infection.
Primary outcome measures
- Clinical response to phage therapy as determined by participant's absence of physical clinical symptoms including wound drainage, swelling, erythema, pain, and fever. [Time frame: 1 year]
Secondary outcome measures (1)
- Safety and tolerability of phage therapy determined by incidence of treatment-emergent adverse events [Time frame: 29 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Foothills Medical Centre, University of Calgary — Calgary
Identifiers
NCT: NCT07461337 · REB26-0079