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AuthorisedTherapeutic exploratory (Phase II)Interventional

Osteoarticular infections on equipment: impact of three probabilistic antibiotic therapy strategies on the digestive microbiota and gastrointestinal colonization with multidrug-resistant bacteria

This study is investigating how different antibiotic treatments for bone and joint infections, especially those around medical implants, impact the natural balance of bacteria in your gut. Our bodies contain trillions of tiny organisms, many of which are beneficial. When we take antibiotics, it can sometimes affect these helpful germs and allow more harmful, drug-resistant bacteria to grow and spread in our digestive system. Researchers are comparing three different ways of giving antibiotics to see which one is gentler on your gut bacteria while still effectively treating the infection. The goal is to find better ways to treat these infections that cause fewer unwanted side effects in your digestive system and reduce the risk of developing hard-to-treat infections.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Centre Hospitalier Universitaire De Nice
Enrolment target
75
Start
03 Feb 2025

What is this study about?

This research is looking into a particular type of infection called an osteoarticular infection, which affects bones and joints, especially if you have medical equipment like artificial joints or plates in your body. When you have these infections, antibiotics are usually needed to help you get better. However, antibiotics don't just kill the bad bacteria causing the infection; they can also affect the good bacteria that naturally live in your gut.

These good gut bacteria are really important for your health. When their balance is upset, it can sometimes lead to tummy troubles or even allow harmful bacteria that are resistant to antibiotics to grow more easily. These drug-resistant bacteria can be very difficult to treat, so doctors are always looking for ways to use antibiotics effectively while protecting your natural gut environment.

This study compares three different ways of giving antibiotics to patients with these bone and joint infections. By looking closely at the types of bacteria in your gut before, during, and after treatment, researchers hope to understand which antibiotic strategy has the least negative impact on your gut's natural balance. The aim is to find out which treatment approach is best for fighting the infection while also keeping your gut healthy and reducing the risk of future problems with drug-resistant bacteria.

Key takeaways

  • Study examines antibiotic effects on gut bacteria in bone/joint infections.
  • Compares three antibiotic strategies.
  • Aims to protect healthy gut balance.
  • Could lead to better, kinder treatments.
  • For adults with bone/joint infections involving medical devices.
  • Participation involves antibiotic treatment and gut bacteria checks.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of any adult age can potentially join.

This study is open to both men and women. Your sex is not a factor in whether you can participate.

The main requirement for this study is that you have an osteoarticular infection related to medical equipment. This means an infection in your bones or joints that involves medical devices, like a joint replacement or a plate used to fix a broken bone.

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.

  1. Are you 18 years old or older?
  2. Do you have an infection in your bone or joint that involves a medical implant?
  3. Are you able to agree to the study procedures?
  4. Are you able to attend study visits if required?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three different antibiotic treatment plans. This will involve receiving specific antibiotics, which will typically be given as an injection or through a drip into your arm. The medical team will explain exactly how your medication will be given and for how long.

Throughout the study, the researchers will collect samples, likely stool samples, to check the types of bacteria living in your gut. They will do this before you start treatment, during your treatment, and potentially for a period afterwards. These samples will help them understand how the antibiotics are affecting your gut bacteria over time.

There will also be regular check-ups with the study team to monitor your health, how you're responding to the treatment, and to see if you experience any side effects. The total length of your participation will depend on the antibiotic treatment you receive and the follow-up period required, all of which will be fully explained before you agree to join.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving closely monitored care for your infection and contributing to medical knowledge that could improve future treatments for others. However, as with any medical treatment, there are potential risks associated with the antibiotics, which could include side effects like allergic reactions, digestive upset, or other issues – your doctor will discuss these with you. There are no guaranteed personal benefits from participating, but your involvement is valuable for research. It is very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting the standard of care you receive for your infection.

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 an osteoarticular infection?

It's an infection that affects your bones or joints, particularly if you have a medical implant or device in that area.

What does 'gut microbiota' mean?

It refers to all the good and bad bacteria, and other tiny organisms, that naturally live in your digestive system, mainly in your intestines.

Why are antibiotics being studied this way?

Researchers want to find out which antibiotic treatment for bone and joint infections causes the fewest problems for the helpful bacteria in your gut.

Will I know which antibiotic treatment I'm getting?

Your study doctor will explain which treatment group you are in and what medications you will receive.

What are 'multidrug-resistant bacteria'?

These are types of bacteria that are difficult to treat because they have become resistant to several different antibiotics.

How to find out more

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

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