A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to assess the safety and efficacy of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated by DAIR
This study, called a Phase II trial, is looking into a new treatment for infections that can happen in artificial hip or knee joints. These infections are often caused by a germ called Staphylococcus aureus. The treatment being tested is called 'phage therapy,' which uses natural viruses (phages) to specifically target and kill bacteria. For this study, patients will also have a procedure called DAIR, which involves cleaning the infected joint and usually changing some parts of the prosthesis. Researchers want to see how safe this phage therapy is and how well it works to clear the infection over three months. They will also compare it to standard care to understand its effectiveness.
At a glance
What is this study about?
This study is a medical research project designed to explore a new treatment for infections in artificial hip or knee joints. Sometimes, after a hip or knee replacement, a joint can get infected. A common type of germ that causes these infections is called Staphylococcus aureus.
The new treatment being investigated is called 'phage therapy.' Phages are actually tiny viruses that can specifically attack and destroy bacteria without harming human cells. This study aims to see if combining phage therapy with a procedure called DAIR (Debridement, Antibiotics, and Implant Retention) can safely and effectively treat these infections. DAIR involves thoroughly cleaning the infected joint and often replacing some parts of the artificial joint while keeping the main implant.
The main goals of this study are to find out if phage therapy is safe (by tracking any serious side effects) and how well it helps clear the infection within three months. Researchers will also be looking at how many patients are cured in the longer term (up to a year) and monitoring their overall health and quality of life.
Key takeaways
- Tests a new 'phage therapy' for hip/knee joint infections.
- Specifically targets Staphylococcus aureus bacteria.
- Combines new therapy with joint cleaning (DAIR).
- Aims to check safety and effectiveness.
- Participation lasts up to 12 months.
- You might receive either the new treatment or a comparison.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.
Crucially, you would need to have an artificial hip or knee joint infection that has been specifically caused by the Staphylococcus aureus germ. This would typically be diagnosed by your medical team.
There will also be other specific medical criteria that your doctor will need to check to make sure the study is a safe and suitable option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have an artificial hip or knee joint infection?
- Has your infection been confirmed to be caused by 'Staphylococcus aureus'?
- Are you willing to have regular medical checks and follow-up for up to a year?
What does participation involve?
If you join this study, you would receive either the new phage therapy treatment or a standard saline solution (which acts as a comparison). You won't know which one you're receiving, nor will your doctors, to ensure fair results. Alongside this, you would undergo the DAIR procedure to clean your infected joint.
Throughout the study, which could last up to 12 months, you would have several hospital visits. These visits will involve various medical checks such as blood tests, heart checks (ECG/Echocardiography), and measurements of your vital signs. Doctors will also monitor your infection closely to see if it clears up. You'll also be asked to complete questionnaires about your quality of life, and X-rays will be taken to check on your joint. All serious health issues will be closely monitored for three months. The total duration of your participation, including follow-up, could be up to 12 months.
Potential risks and benefits
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Common questions
What is 'phage therapy'?
Phage therapy uses natural viruses called 'phages' that specifically attack and destroy harmful bacteria, like Staphylococcus aureus, without harming your own cells.
What does 'DAIR' mean?
DAIR stands for Debridement, Antibiotics, and Implant Retention. It's a procedure where surgeons clean an infected joint and usually replace some parts of the implant while keeping the main artificial joint.
Will I know if I'm getting the new treatment or a comparison?
No, in this type of study (double-blind), neither you nor your doctors will know whether you are receiving the new phage therapy or the standard saline solution. This helps ensure the study results are unbiased.
How long will I be in the study?
Your involvement in the study could last for up to 12 months, including initial treatment and follow-up appointments.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, and this will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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