Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Bacteriophage Therapy for Methicillin-Sensitive Staphylococcus Aureus Prosthetic Joint Infection

This study is looking at a new treatment called 'phage therapy' for a serious hip joint infection caused by a common germ called Staphylococcus aureus. The patient in this study has tried all standard treatments, including many operations and strong antibiotics, with no luck. Phage therapy uses special viruses, called bacteriophages or phages, that are designed to attack and kill only the harmful bacteria causing the infection. The aim is to see if this new treatment can get rid of the infection for good and stop it from returning. This treatment involves a one-time injection into the hip joint and then daily medicine through a drip for two weeks. It's hoped this could offer a new solution for very stubborn infections.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Calgary

Enrolment target

Start

20 Nov 2024

Estimated completion

01 Nov 2025

Prosthetic Joint Infections of Hip Staphylococcus Aureus Infection

What is this study about?

This study is testing a new way to fight a difficult infection in a hip replacement, caused by a germ called Staphylococcus aureus. This particular patient has had a lot of trouble with this infection, even after many usual treatments like operations and strong antibiotics. Because nothing else has worked, doctors are now trying something different called 'phage therapy'.

Phages are tiny viruses that are natural enemies of bacteria. Each type of phage is usually very good at attacking and destroying a specific type of germ, without harming human cells. In this study, doctors will use a special mix of phages that are known to kill the specific germ causing this patient’s infection. The hope is that these phages can get rid of the infection where other medicines have failed.

The idea is to inject these phages directly into the infected hip joint during an operation and then give them through a drip into the patient's bloodstream for two weeks. The doctors will watch the patient very closely for a year to see if the infection goes away and stays away. Success in this single case could be a big step towards helping many other patients with severe and hard-to-treat infections.

Key takeaways

Tests a new treatment (phage therapy) for a stubborn hip joint infection.
Phages are special viruses that kill specific bacteria.
For one patient who has exhausted all other treatment options.
Involves a hip injection and a 2-week drip treatment.
Patient will be closely monitored for a year after treatment.
Could offer a new solution for very difficult infections.

Who may be eligible?

This study is for one specific patient who has a long-lasting infection in their artificial hip joint. The infection is caused by a germ that doctors have found can be killed by the phage treatment in laboratory tests. Importantly, this patient must have already tried many different antibiotic medicines and operations without success.

There are certain reasons why someone can't take part. These include having very serious kidney or liver disease, or if they've had an allergic reaction to phage products before. Also, if they have a fever, are taking part in another study, or if they are pregnant, they cannot join. This particular study is only open to men.

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.

Do I have a long-term infection in an artificial joint?
Has my infection not improved despite trying many antibiotics and operations?
Am I generally healthy, (e.g., not having very serious kidney or liver problems)?
Am I aware if I have any known allergies to phage products?
Am I a man (this specific study is only for men)?

Answer every question to see your result.

What does participation involve?

If you were to take part in a study like this, it would involve several steps. First, the treatment involves a single injection of the phage mixture directly into your hip joint during an operation. Following this, you would receive the phage medicine through a drip into your arm, twice a day, for 14 days.

Throughout your participation, you would have regular check-ups, which include physical examinations, blood tests, and possibly scans, to make sure the treatment is working and that you are reacting well. You would be monitored very closely for any immediate effects of the treatment. These check-ups would continue for a full year after the treatment to make sure the infection has gone and hasn't returned. The total time you would be involved in the study, including follow-up, is 12 months.

Potential risks and benefits

The main potential benefit of this study is that it might offer a new way to treat a very stubborn infection that standard treatments haven't been able to clear. This could greatly improve the patient's quality of life. As with any new treatment, there might be unknown risks or side effects, especially since this is a first-time treatment for this patient. Doctors will monitor the patient very carefully for any problems. You would always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

South Health Campus
Verified postcode
Calgary, Canada

Common questions

What exactly is 'phage therapy'?

Phage therapy uses natural viruses, called bacteriophages, that specifically hunt down and kill bacteria. They are like tiny, targeted weapons against germs.

Is this a common treatment?

No, it's a very new and experimental treatment, especially for joint infections. It's often tried when standard medicines haven't worked.

What are 'Staphylococcus aureus' and 'Prosthetic Joint Infection'?

Staphylococcus aureus is a common type of bacteria. A prosthetic joint infection means an artificial joint, like a hip replacement, has become infected by germs.

Will the viruses harm me?

The phages used in this treatment are designed to only attack specific bacteria and not human cells. Your doctors will watch you very closely for any reactions.

How long does the study last?

The treatment itself is for 14 days, but doctors will follow up with the patient for a full year to check on their health and the infection.