Phage Therapy for Staph Infection

(PHAGE-2024-01 Trial)

Overseen By Benson Weyant, MD

Age: Any Age

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: University of Calgary

Disqualifiers: Stage 5 kidney disease, Cirrhosis, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Phage therapy for Staph Infection?

Research shows that phage therapy was effective in treating 93% of staph infections, including those resistant to antibiotics. Additionally, studies in animals demonstrated that phage therapy improved survival rates and reduced bacterial loads in infections caused by methicillin-resistant Staphylococcus aureus (MRSA). ^{1 2 3 4 5}

Is phage therapy safe for humans?

Phage therapy has been studied for safety in both animals and humans, with serious side effects being extremely rare. Historical and recent studies, including those involving intravenous use, suggest that phage therapy is generally safe, though some mild adverse effects have been reported, often related to impurities in the phage preparations. ^{2 6 7 8 9}

How is phage therapy different from other treatments for Staph infections?

Phage therapy is unique because it uses viruses called bacteriophages to specifically target and kill bacteria like Staphylococcus aureus, including antibiotic-resistant strains like MRSA. Unlike antibiotics, which can affect a broad range of bacteria, phages are highly specific and can be less expensive, offering a targeted approach with fewer side effects. ^{1 2 3 4 10}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for someone with a chronic hip joint infection caused by methicillin-sensitive Staphylococcus aureus, who has tried multiple antibiotics and surgeries without success. The bacteria causing their infection must respond to bacteriophage therapy in lab tests.

Inclusion Criteria

I have an ongoing infection in my artificial joint.

The bacteria causing my infection can be treated with bacteriophage therapy.

I've had several unsuccessful antibiotic treatments and surgeries.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Administration of bacteriophage therapy, including intra-operative injection and 14 days of intravenous phage therapy

2 weeks

Daily visits for intravenous therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including regular physical examinations and blood tests

12 months

Monthly assessments

Treatment Details

Interventions

• Phage therapy

Trial Overview The study is testing a one-time injection of a bacteriophage cocktail directly into the infected hip joint during surgery, followed by two weeks of intravenous phage therapy. It aims to clear the infection and prevent it from coming back.

Participant Groups

Group I: Open Label Arm Experimental Treatment 1 Intervention

Bacteriophage cocktail

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Precisio Biotix Therapeutics, Inc.

Industry Sponsor

Trials

3

Recruited

80+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Results of bacteriophage treatment of suppurative bacterial infections. VI. Analysis of treatment of suppurative staphylococcal infections. [2007]

2. Iran pubmed.ncbi.nlm.nih.gov

Isolation, characterization, and antibacterial activity of lytic bacteriophage against methicillin-resistant Staphylococcus aureus causing bedsore and diabetic wounds. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Experimental phage therapy against lethal lung-derived septicemia caused by Staphylococcus aureus in mice. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Phage therapy of staphylococcal infections (including MRSA) may be less expensive than antibiotic treatment. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Bacteriophages Improve Outcomes in Experimental Staphylococcus aureus Ventilator-associated Pneumonia. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety and Toxicity of Phage Therapy: A Review of Animal and Clinical Studies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of phage therapy via the intravenous route. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Phage Therapy for Bone and Joint Infections: A Systematic Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Immunological and safety profile of bacteriophage therapy: A pre-clinical study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Phenotypic and Genotypic Characterization of Novel Polyvalent Bacteriophages With Potent In Vitro Activity Against an International Collection of Genetically Diverse Staphylococcus aureus. [2022]