Study on the Impact of Cefepime, Piperacillin-Tazobactam, and Ceftobiprole on Gut Health in Patients with Bone and Joint Infections on Implants

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What is this study about?

This clinical trial focuses on studying infections that occur in bones and joints, particularly those involving medical equipment like prosthetic joints. These are known as osteomyelitis and septic arthritis. The study aims to understand how different antibiotic treatments affect the bacteria in the digestive system. The antibiotics being tested include cefepime, daptomycin, piperacillin-tazobactam, and ceftobiprole. These medications are used to treat serious bacterial infections and are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to compare how these antibiotics impact the variety of bacteria in the gut over a short period, specifically from the first day to the fifth day of treatment. This is important because antibiotics can sometimes disrupt the balance of bacteria in the gut, which can lead to other health issues. The study will involve patients who are suspected of having an infection related to their prosthetic or other medical equipment. The diversity of each patient’s gut bacteria will be analyzed using a method called 16S rDNA metagenomics, which is a way to study the genetic material of bacteria to understand their variety and abundance.

Participants in the study will receive one of the antibiotic treatments mentioned above, or a combination of them, for a maximum of five days. The study will help researchers understand which antibiotic or combination of antibiotics is most effective in treating these infections while having the least impact on the gut bacteria. This information could lead to better treatment strategies for patients with bone and joint infections related to medical equipment.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and the need for prosthetic revision or similar procedures.

A normal CPK level, which is a blood test to check muscle health, is required.

2 treatment initiation

The treatment involves one of three antibiotic strategies to address suspected osteoarticular infections on equipment.

The options include: cefepime combined with daptomycin, piperacillin-tazobactam combined with daptomycin, or ceftobiprole alone.

3 medication administration

Medications are administered through IV infusion, which means they are given directly into a vein.

The specific dosages are: Daptomycin Xellia 500 mg or 350 mg, Piperacillin/Tazobactam Viatris 4 g/0.5 g, MABELIO 500 mg, and CEFEPIME VIATRIS 2 g.

4 monitoring and evaluation

The main objective is to compare changes in gut microbiota diversity from day 1 to day 5 of treatment.

This involves analyzing the gut bacteria using a method called 16S rDNA metagenomics.

5 study duration

The study is expected to continue until May 31, 2027.

Recruitment for the study is anticipated to start on February 3, 2025.

Who Can Join the Study?

Must be 18 years old or older.
Need to have a reason for prosthetic revision, which means replacing or fixing a joint replacement, or a total shoulder prosthesis, which is a shoulder joint replacement, or a revision of internal osteosynthesis material, which involves fixing or replacing metal parts used to hold bones together, with a suspicion of ostearticular infection on material (IOAM), which is an infection in the bones or joints related to medical equipment.
Must have a normal CPK level, which is a blood test that measures an enzyme called creatine phosphokinase, according to the standard set by the laboratory.
Both men and women can participate.
Participants should not be from a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

Patients with ostearticular infections on equipment cannot participate. This means infections in bones or joints that involve medical devices like implants.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might be at higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier D’Antibes Juan Les Pins	Antibes	France
Centre Hospitalier De Cannes Simone Veil	Cannes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Cxwcyd Hdkrewlisxh dl Gzvaiz	Grasse	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	03.02.2025

Trial locations

Investigated drugs:

Cefepime is an antibiotic used to treat a variety of bacterial infections. It works by stopping the growth of bacteria. In this trial, it is used in combination with another antibiotic to see how it affects the gut microbiota in patients with suspected bone and joint infections.

Daptomycin is an antibiotic that is used to treat certain serious bacterial infections. It works by killing bacteria. In this study, it is combined with other antibiotics to evaluate its impact on the gut microbiota in patients with suspected infections related to medical equipment.

Piperacillin-Tazobactam is a combination of two antibiotics that work together to treat a wide range of bacterial infections. Piperacillin kills bacteria, while tazobactam prevents certain bacteria from becoming resistant to piperacillin. This combination is used in the trial to assess its effect on the gut microbiota in patients with suspected bone and joint infections.

Ceftobiprole is an antibiotic used to treat certain types of bacterial infections. It works by interfering with the formation of the bacteria’s cell wall, which results in the death of the bacteria. In this clinical trial, it is used to study its impact on the gut microbiota in patients with suspected infections related to medical equipment.

Investigated diseases:

Medical device site joint infection

Osteoarticular infections on equipment – These infections occur when bacteria invade the bones or joints, often involving medical devices like prosthetic joints or surgical hardware. The infection can lead to inflammation, pain, and swelling in the affected area. Over time, the infection may cause damage to the bone and surrounding tissues, potentially leading to joint dysfunction. The presence of foreign material, such as implants, can make these infections more challenging to manage. The progression of the infection depends on the type of bacteria involved and the body’s response to the infection.

Trial ID:

2024-513298-29-00

Protocol code:

22-CONS-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Impact of Cefepime, Piperacillin-Tazobactam, and Ceftobiprole on Gut Health in Patients with Bone and Joint Infections on Implants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?