Study on the Effects of Rifampicin, Amoxicillin, and Moxifloxacin in Treating Prosthetic Joint Infections Caused by Cutibacterium acnes for Affected Patients

4 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of the antibiotic rifampicin in treating infections caused by Cutibacterium acnes in people who have had joint replacement surgery, such as knee, hip, or shoulder replacements. These infections are known as prosthetic joint infections. The study aims to understand how safe and effective rifampicin is when used to treat these infections.

Participants in the study will receive treatment for up to 12 weeks. The study will compare rifampicin with other antibiotics, including amoxicillin, moxifloxacin, clindamycin, and doxycycline, to see how well they work in managing the infection. Some participants may receive a placebo. The study will monitor the participants for any signs of the infection returning or new infections developing, as well as any side effects from the medications.

The goal is to gather information over a period of time to determine the best treatment approach for managing Cutibacterium acnes infections in joint replacements. The study will also look at how often these infections fail to be managed successfully and any adverse effects linked to the use of rifampicin. Participants will be followed up for up to 24 months to assess the long-term outcomes of the treatment.

1 joining the trial

Upon joining the clinical trial, the patient will be informed about the study’s objectives and procedures. The trial aims to evaluate the safety and effectiveness of rifampicin in treating Cutibacterium acnes prosthetic joint infections.

The patient will be required to provide consent to participate in the study, acknowledging understanding of the trial’s purpose and procedures.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying age (18 years or older) and confirming the presence of a monomicrobial infection caused by Cutibacterium acnes in a prosthetic joint.

The infection must be susceptible to rifampicin and treated surgically with either a single-stage or two-stage revision.

3 treatment phase

During the treatment phase, the patient will receive medications orally. The specific medications used may include amoxicillin or moxifloxacin, based on the patient’s medical history and the infection’s susceptibility.

The dosage, frequency, and duration of medication administration will be determined by the healthcare provider overseeing the trial.

4 monitoring and follow-up

Throughout the trial, the patient will be monitored for any adverse events related to rifampicin. These events will be classified according to their frequency and severity.

The patient will have regular follow-up appointments to assess the treatment’s effectiveness and to check for any signs of infection recurrence or new infections.

5 end of trial

The trial is expected to continue until July 2027. The patient will be followed up for a period of up to 24 months to evaluate the long-term outcomes of the treatment.

At the end of the trial, the patient will receive a summary of their participation and any relevant findings related to their treatment.

Who Can Join the Study?

Age: You must be 18 years or older.
You must have an infection in a joint replacement (like knee, hip, or shoulder) caused by a specific bacteria called Cutibacterium acnes. This infection should be treated surgically with either a one-step or two-step revision.
The presence of C. acnes must be confirmed in two separate samples taken during surgery. At least one sample must be confirmed using a standard culture method. Other advanced methods like 16s rDNA sequencing or metagenomic sequencing can also be used to confirm the presence of the bacteria.
Based on tests that show which antibiotics the bacteria are sensitive to, and your medical history, the infection should be treatable with either amoxicillin or moxifloxacin.

Who Cannot Join the Study?

Patients with any other serious infections that are not related to the study.
Patients who have allergies to the study medication or similar medications.
Patients who are currently participating in another clinical trial.
Patients with liver disease or any condition affecting the liver.
Patients with kidney disease or any condition affecting the kidneys.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have had a major surgery within the last 30 days.
Patients with immune system disorders that affect the body’s ability to fight infections.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Hospital Edouard Herriot	Lyon	France
Hopital Purpan	Toulouse	France
Csc dmpoxvxrrnudha	Epagny Metz Tessy	France
Aqgpvrkadx Prdrutql Hheobkxz Do Mefzltmoe	Marseille	France
Crmbpa Hnqsddmxzuc Rveevwdk Umodaodbqznju Du Tptci	Tours	France
Cqz Cxdyx Rrxqxinledr	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Rifampicin is a medication used in this clinical trial to treat infections caused by a type of bacteria called Cutibacterium acnes, which can affect prosthetic joints. The trial is investigating how safe and effective rifampicin is when used for this specific type of infection. Rifampicin works by stopping the bacteria from making essential proteins, which helps to kill the bacteria and clear the infection. This medication is often used in combination with other antibiotics to ensure a more effective treatment and to prevent the bacteria from becoming resistant to the medication.

Investigated diseases:

Medical device site joint infection

Cutibacterium acnes prosthetic joint infection – This infection occurs when the bacterium Cutibacterium acnes, which is commonly found on the skin, infects a joint that has been replaced with a prosthetic implant. The infection can develop slowly over time, often presenting with subtle symptoms such as joint pain, swelling, and reduced mobility. As the infection progresses, it may lead to more noticeable signs like redness, warmth, and fluid accumulation around the joint. The condition can cause inflammation and damage to the surrounding tissues, potentially leading to joint instability. In some cases, the infection may not be immediately apparent and can be difficult to diagnose due to its slow progression and mild initial symptoms.

Trial ID:

2022-502974-18-00

Protocol code:

21-APN-02

NCT ID:

NCT05902221

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Rifampicin, Amoxicillin, and Moxifloxacin in Treating Prosthetic Joint Infections Caused by Cutibacterium acnes for Affected Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?