Bacteriophage Therapy for Staphylococcus Lugdunensis Prosthetic Joint Infection
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of active chronic prosthetic joint infection
Causative bacteria is susceptible to bacteriophage therapy in vitro
History of multiple failed antibiotic and surgical interventions
Disqualifiers
Stage 5 chronic kidney disease
Cirrhosis
A known allergy to phage products
Fever
Trial design
Design model
Single group
Treatments tested in this trial
Five phage anti-Staphylococcus aureus bacteriophage cocktail
Biological/VaccineFive phage anti-Staphylococcus aureus bacteriophage cocktail for targeted treatment of a Staphylococcus lugdunensis infection.
Treatment groups
1 Participants
are divided into 1 treatment groupGroup A: Bacteriophage drug productExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 daysSponsors and contacts
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University of Calgary
Lead sponsor
Qeen Biotechnologies
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: