Bacteriophage Therapy for Prosthetic Hip Joint Infection

JN
TN
Overseen ByTeresa Nguyen
Age: Any Age
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for infections in hip joint replacements, specifically targeting hard-to-treat bacteria called Staphylococcus lugdunensis. The treatment uses a special virus, a bacteriophage, to attack these bacteria, aiming to stop the infection and prevent its return. This treatment is a five-phage anti-Staphylococcus aureus bacteriophage cocktail. It involves injections directly into the joint and a two-week course of intravenous therapy. Ideal participants are those with ongoing hip joint infections that standard surgeries or antibiotics have not cured. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for this trial?

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 this treatment is likely to be safe for humans?

Research has shown that bacteriophage therapy, including a special mix of five phages targeting Staphylococcus aureus, holds promise for treating joint infections. Reviews have noted that this treatment is safe when combined with other methods for infections caused by bacteria like Staphylococcus aureus.

In one study, 33 patients with hip and knee joint infections received phage cocktails, and the results suggested that these treatments were generally well-tolerated. Another case demonstrated that a personalized phage therapy, combined with an antibiotic, was safe and effective in eliminating a difficult infection.

The results so far are encouraging and suggest that this therapy does not cause significant harm. However, as the treatment remains under study, further research is needed to confirm its safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prosthetic hip joint infections, which typically involve antibiotics and sometimes surgery, this new therapy uses a bacteriophage cocktail specifically targeting Staphylococcus aureus. Bacteriophages are viruses that naturally infect and kill bacteria, offering a potentially precise and effective way to combat infections without harming human cells. Researchers are excited because this approach could overcome antibiotic resistance, a growing problem with traditional treatments. Additionally, the use of a phage cocktail can target multiple bacterial strains, making it a versatile and potentially powerful option.

What evidence suggests that this treatment might be an effective treatment for prosthetic hip joint infection?

Research has shown that bacteriophage therapy, which uses viruses to attack bacteria, can effectively treat infections in prosthetic joints. This trial will evaluate the effectiveness of a five-phage anti-Staphylococcus aureus bacteriophage cocktail. One study found that combining phages with the antibiotic vancomycin reduced bacteria in joint tissues by 22.5 times. Other reports highlight the successful use of phage therapy for challenging infections in prosthetic and heart devices. Additional studies indicate that phage therapy alone can significantly reduce bacteria in infected areas, making it a promising treatment option. Overall, these findings suggest that phage therapy could help treat and manage difficult infections when other treatments have failed.16789

Are You a Good Fit for This Trial?

This trial is for people with a chronic hip joint infection caused by Staphylococcus lugdunensis, whose infection hasn't improved after multiple surgeries and antibiotics. Participants must not be pregnant, have severe kidney or liver disease, fever, allergies to phage products, or be in another clinical trial.

Inclusion Criteria

I have an active infection in my artificial joint.
My infection is caused by bacteria that respond to bacteriophage therapy.
I have had several unsuccessful antibiotic treatments and surgeries.

Exclusion Criteria

Pregnancy
I currently have a fever.
I have stage 5 chronic kidney disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 2 intra-articular injections of bacteriophages and 14 days of intravenous phage therapy

2 weeks
2 visits (in-person) for injections, daily monitoring for intravenous therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including regular clinical assessments and routine bloodwork

29 days
Regular visits for clinical assessments and bloodwork

Long-term follow-up

Participants are monitored for recurrence of infection and absence of clinical symptoms over a year

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Five phage anti-Staphylococcus aureus bacteriophage cocktail

Trial Overview

The study tests a mix of five bacteriophages given as two injections into the infected hip joint plus two weeks of IV therapy. The goal is to see if this new treatment can clear stubborn infections when standard treatments have failed.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Bacteriophage drug productExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Qeen Biotechnologies

Industry Sponsor

Citations

Phage therapy in prosthetic joint infections caused by ... - PMC

The combination of the phage cocktail with vancomycin resulted in a 22.5-fold diminution in bacterial load of joint tissues, again in comparison ...

The promising role of bacteriophage therapy in managing total ...

Bacteriophage therapy (BT) was used as an adjuvant for PJI management, aiming at treating resistant infections, decreasing morbidity, and mortality.

Successful Treatment of Staphylococcus aureus Prosthetic ...

There are several recent reports of successful outcomes using bacteriophage therapy (BT) for prosthetic and cardiac device infections [8,9,12–14] ...

Evaluation of bacteriophage as an adjunct therapy for ...

Treatment with phage alone or vancomycin alone, led to 5-fold and 6.2- fold reductions, respectively in bacterial load within peri-implant ...

Evaluation of bacteriophage as an adjunct therapy for ...

Treatment with phage alone or vancomycin alone, led to 5-fold and 6.2-fold reductions, respectively in bacterial load within peri-implant tissue ...

Bacteriophages in Hip and Knee Periprosthetic Joint Infections

Staphylococcus aureus was the most frequent pathogen (18 cases); phage cocktails were used in 33 patients and monophage preparations in 9, all ...

Activity of a Phage Collection Against Staphylococci from ...

Phages are being assessed for treatment of periprosthetic joint infection (PJI). Staphylococci are the most common cause of PJI.

Phage Therapy for Bone and Joint Infections

Similarly, 3D-printed calcium phosphate ceramics loaded with a phage cocktail against heterogeneous S. aureus and E. coli populations successfully prevented ...

Phage therapy for bone and joint infections

The review unveils the dynamics of phages, including their origins, lifecycle outcomes, and genomic characteristics. Animal studies, in vitro investigations, ...