Phage Therapy for Staph Infection
(PHAGE-2024-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called phage therapy, which uses viruses to target bacteria, to address stubborn hip joint infections caused by Staphylococcus aureus. The goal is to determine if this approach can clear the infection and prevent its recurrence, particularly for those who haven't succeeded with other treatments. Participants should have a long-term hip joint infection that hasn't improved despite multiple antibiotics and surgeries. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
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.
Is there any evidence suggesting that phage therapy is likely to be safe for humans?
Research has shown that phage therapy is generally safe for treating severe Staphylococcus aureus infections. Studies have found that a specific mix of bacteriophages, called AB-SA01, is well-tolerated, even in serious conditions like heart infections and septic shock, meaning the treatment usually doesn't cause harmful side effects.
Further research supports that phage therapy can effectively reduce infections and help wounds heal faster in infected areas. Animal tests have studied both injecting phages into the vein and applying them directly to the infection for safety and effectiveness.
The trial for phage therapy involves administering it directly into the joint and through the veins. This method is being tested because earlier research showed positive results in treating stubborn Staphylococcus infections. Although the trial is still in its early stages, existing data on phage therapy's safety is promising for potential participants.12345Why do researchers think this study treatment might be promising?
Phage therapy is unique because it uses bacteriophages, which are viruses that specifically target and destroy bacteria, to treat infections like those caused by Staphylococcus. Unlike antibiotics, which can sometimes lead to resistance and affect beneficial bacteria, phages are highly specific, targeting only the harmful bacteria. Researchers are excited about this treatment because it offers a promising alternative that could potentially overcome antibiotic resistance and provide a targeted, efficient way to eliminate stubborn bacterial infections.
What evidence suggests that phage therapy might be an effective treatment for Staph infection?
Research has shown that phage therapy, which uses viruses to attack bacteria, could help treat Staphylococcus aureus infections. One study found that using phage therapy soon after infection prevented abscesses from forming. Another review noted that phage therapy might work well alongside other treatments for Staphylococcus infections, even in challenging cases involving biofilms. Clinical data indicates that about 77% of infections improved with phage therapy, and 61% of the bacteria were completely eliminated. These findings suggest that phage therapy, which participants in this trial will receive, could be an effective option for treating stubborn infections.34567
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Administration of bacteriophage therapy, including intra-operative injection and 14 days of intravenous phage therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including regular physical examinations and blood tests
What Are the Treatments Tested in This Trial?
Interventions
- Phage therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Precisio Biotix Therapeutics, Inc.
Industry Sponsor
University of Toronto
Collaborator