RecruitingPHASE3INTERVENTIONAL

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

This study is looking at new ways to treat infections in artificial joints, such as replacement hips or knees. These infections are often caused by a type of germ called staphylococcus. Currently, a medicine called rifampicin is very important for treating them. However, rifampicin can sometimes cause side effects, particularly with the liver, and can interfere with other medicines people might be taking. Researchers are investigating another medicine called rifabutin. They believe rifabutin might work just as well as rifampicin but could be safer and cause fewer problems. The main goal is to find out if rifabutin is equally effective in treating these joint infections while having a better safety profile for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Tourcoing Hospital

Enrolment target

436

Start

08 Nov 2021

Estimated completion

01 Jun 2027

Prosthetic Infection

What is this study about?

When people have an artificial joint replacement, like a new hip or knee, there's a small chance it could get infected. This type of infection is called a prosthetic joint infection (PJI) and it can be quite serious. Doctors often use a strong medicine called rifampicin to help get rid of these infections, especially those caused by a common germ called staphylococcus.

However, rifampicin can sometimes cause problems. For example, it can affect the liver, and it can also interact with other medicines you might be taking, making them less effective or causing more side effects. This means doctors have to be very careful when prescribing it, especially if you're on other long-term medications.

This study is comparing rifampicin with another medicine called rifabutin. The doctors think rifabutin might be just as good at clearing up these infections as rifampicin. But, importantly, they hope rifabutin will have fewer side effects, especially concerning the liver, and will be less likely to interfere with your other medicines. Finding a treatment that is both effective and safer could be a big step forward for people with these joint infections.

Key takeaways

This study is about making treatment for joint infections safer.
It compares two medicines: rifabutin and rifampicin.
The goal is to find out if rifabutin is just as effective but has fewer side effects.
It's for adults with staphylococcus infections in artificial hips or knees.
Participants will be closely monitored throughout the study.

Who may be eligible?

This study is for adults aged 18 or older who have an infection in their artificial hip or knee joint. The infection must have been treated with a procedure called DAIR, which involves cleaning the joint and starting antibiotics while keeping the artificial joint in place. The infection needs to be caused by specific germs called staphylococcus.

The germs causing your infection must respond well to both rifampicin and at least one other antibiotic that doctors use for these types of infections. You also need to be able to sign a consent form to show you understand and agree to take part, and be eligible for French social insurance (as this study is likely based in France).

There are also some reasons why you wouldn't be able to join. For example, if you have certain gut problems that might affect how well you absorb medicines, if you're allergic to rifabutin or rifampicin, or if your infection is caused by many different types of germs (unless it's just staphylococcus). Also, if you have a serious heart infection (endocarditis) linked to your joint infection, or severe kidney disease, you wouldn't be able to participate.

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 or older?
Do you have a staphylococcus infection in your artificial hip or knee?
Has your infection been treated with the DAIR method?
Are you able to take rifabutin or rifampicin (no known allergies)?
Do you have any conditions, like severe kidney disease, that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

The study involves taking either rifabutin or rifampicin as part of your treatment for the joint infection. You will have regular check-ups and tests, such as blood tests, to see how you are responding to the medication and to monitor for any side effects. You will be closely watched by the medical team throughout the study. The total duration of the medication and follow-up will depend on your individual treatment plan, but usually involves several weeks to months of antibiotics. Specific details on exact visits and assessments would be discussed with your study doctor.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a potentially safer treatment option for your joint infection, if rifabutin proves to have fewer side effects than rifampicin. However, there's always a possibility of experiencing side effects from any medication, including rifabutin or rifampicin. You'll be closely monitored for these. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (30)

CHU Amiens Picardie
Verified postcode
Amiens, France· Not yet recruiting
CHU Angers
Verified postcode
Angers, France· Not yet recruiting
CHU Besançon
Verified postcode
Besançon, France· Recruiting
CH de Béthune
Verified postcode
Béthune, France· Not yet recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
APHP Hôpital Ambroise Paré
Verified postcode
Boulogne-Billancourt, France· Not yet recruiting
CHRU Brest
Verified postcode
Brest, France· Recruiting
CHU Caen
Verified postcode
Caen, France· Recruiting
CH Alpes Leman
Verified postcode
Contamine-sur-Arve, France· Not yet recruiting
CHU Dijon Bourgogne
Verified postcode
Dijon, France· Not yet recruiting
CHU Grenoble Alpes
Verified postcode
Grenoble, France· Not yet recruiting
CHRU Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is a 'prosthetic joint infection'?

It's when an artificial joint, like a new hip or knee, gets infected by germs.

What does DAIR mean?

It's a way doctors treat joint infections by cleaning the joint and giving antibiotics, without removing the artificial joint itself.

Why are you comparing rifabutin and rifampicin?

We want to see if rifabutin works as well as rifampicin but has fewer side effects, especially with the liver and other medicines.

Will I know which medicine I'm taking?

No, in this type of study, patients usually don't know if they are getting rifabutin or rifampicin. This helps make the comparison fair.

What kind of germs cause these infections?

Often, they are caused by a type of bacteria called staphylococcus.

How to find out more

Eric SENNEVILLE, MD PhD

esenneville@ch-tourcoing.fr 0320694949 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.