Clinical trial

Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection

Name
REB23-1733
Description
This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of a bacteriophage cocktail to treat and prevent the recurrence of a methicillin-susceptible Staphylococcus aureus prosthetic joint infection of the hip. The patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to his quality of life. The treatment involves a one time, intra-operative injection of bacteriophages into the joint 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.
Trial arms
Trial start
2024-06-01
Estimated PCD
2025-06-01
Trial end
2025-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Phage therapy
Bacteriophage cocktail consisting of phages BP13 and J1P3
Arms:
Open Label Arm
Size
1
Primary endpoint
Clinical response
1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single patient', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ESTIMATED'}}
Updated at
2024-06-13

1 organization

1 product

2 indications