Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PhagoDAIR I : A Pilot, Multicenter, Randomized, Non Comparative, Double-Blind Study of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated with DAIR and Antibiotic Therapy.

This research is testing a new treatment called 'phage therapy' for infections that can happen in artificial hip or knee joints. These infections are often caused by a common type of bacteria called *Staphylococcus aureus*. The study wants to see if adding these phages – which are like tiny, natural viruses that only attack specific bacteria – to the usual treatment helps patients. The standard treatment involves cleaning the joint (called DAIR) and then taking antibiotics. Researchers will be looking to see if the infection is kept under control, if patients feel better, and if the treatment is safe. This is a small, early-stage study to understand more about this potential new approach for a challenging condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Phaxiam Therapeutics

Enrolment target

Start

12 Aug 2024

knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus with the indication of DAIR and Suppressive Antibiotics Therapy (SAT)

What is this study about?

Imagine you've had surgery to replace your hip or knee, and unfortunately, an infection has developed in the new joint. This can be painful and challenging to treat. This study, called PhagoDAIR I, is looking into a new way to fight these infections, specifically when they're caused by a tough-to-beat germ called *Staphylococcus aureus*.

Currently, if you get this type of infection, doctors usually clean the joint thoroughly (a procedure called DAIR) and then give you strong antibiotics. This study is testing if adding something called 'phage therapy' to this standard approach can make it even more successful. Phages are like natural, tiny viruses that are harmless to humans but are very good at finding and killing specific bacteria. They're a bit like targeted superheroes for germs!

The main goal is to see if patients who receive phage therapy, along with their usual treatment, have better control over their infection. This means checking if their pain goes away, if there are no signs of inflammation or fever, and if the *Staphylococcus aureus* bug is successfully cleared from the joint. Researchers will also be carefully monitoring how safe the phage therapy is and how it affects patients' quality of life.

Key takeaways

This study explores a new 'phage' treatment for infected hip or knee implants.
It targets infections caused by the *Staphylococcus aureus* germ.
Phages are natural viruses that kill specific bacteria.
It's an early-stage study to see if phages improve infection control when added to standard treatment.
Researchers will monitor how well the infection is controlled and the treatment's safety.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years old or older) and have an infection in your artificial hip or knee joint. This infection must be caused by a specific type of germ called *Staphylococcus aureus*.

Your doctor must also have decided that the best way to treat your infection is with the standard approach of cleaning the joint (DAIR) and taking antibiotics. This study is looking at adding the phage therapy to this existing treatment plan.

There might be other reasons why you can't join the study, for example, if you have certain other health conditions or are taking particular medications. The study team will review your full medical history to see if you're a good fit.

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 infection in an artificial hip or knee joint?
Has your infection been confirmed as being caused by *Staphylococcus aureus*?
Have your doctors recommended DAIR surgery and antibiotic treatment for your joint infection?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the investigational phage therapy (PP1493 and/or PP1815) or a saline solution (a saltwater solution, which acts as a placebo, meaning it contains no medicine) in addition to your standard care (DAIR surgery and antibiotics). You won't know which one you're receiving, nor will your doctors, to keep the results unbiased.

You will have several hospital visits and appointments where the study team will carry out various checks. These include physical examinations, blood tests (to check your general health and reactions to the treatment), and tests to look for the bacteria. You will also answer questionnaires about your pain, how your joint is working, and your overall quality of life. The doctors will also carefully check your joint for any signs of the infection returning or any problems with your artificial joint. The exact number of visits and the total duration aren't specified but expect regular follow-up over several months to monitor your infection and well-being.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as receiving a new type of treatment that might help control your infection more effectively than standard care alone. However, there are also potential risks, including discomfort from examinations, possible side effects from the investigational treatment, or no benefit from the new therapy. As with any medical procedure, there's always a risk of complications. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is a 'phage'?

A phage is a type of natural virus that specifically targets and kills bacteria without harming human cells. Think of them as very precise germ fighters.

Why is this study 'double-blind'?

Double-blind means neither you nor your doctor will know if you're receiving the actual phage treatment or a placebo (a dummy treatment). This helps ensure the study results are fair and unbiased.

What is *Staphylococcus aureus*?

It's a common type of bacteria that can cause serious infections, including those in artificial joints. Some types can be hard to treat with regular antibiotics.

What does 'DAIR' mean?

DAIR stands for 'Debridement, Antibiotics, and Implant Retention.' It's a surgical cleaning procedure for infected artificial joints, where doctors clean the area and you then take antibiotics, usually without removing the joint.

Will I have to pay to be part of the study?

No, you will not have to pay for the study treatment or for any tests and visits that are directly part of the research.