Fracture infection Trials in Disease

Study on Clindamycin and Rifampicin for Treating Infections in Patients with Obesity, Fracture-Related Infections, Hidradenitis Suppurativa, or Prosthetic Joint Infections

This clinical trial is investigating how the antibiotics clindamycin and rifampicin work in treating certain types of infections, including those that occur at the site of broken bones. The study is particularly interested in understanding how a person's body weight and the use of rifampicin alongside clindamycin might affect how well the treatment works.

Main focus and goals: The primary purpose of this trial is to understand how clindamycin is processed by the body. Researchers want to measure how the medication is absorbed, distributed, and eliminated. They are also examining whether using rifampicin at the same time changes the way clindamycin works. Additionally, the study aims to evaluate how effective these medications are in curing infections related to fractures, as well as other types of infections. The trial will last up to 12 weeks, during which participants will take their medications orally.

Who can participate: To join this trial, you must be at least 18 years old and provide written consent to participate. The study is divided into different groups based on body weight. Some participants will need to have a Body Mass Index (BMI) below 30, while others will need a BMI of 30 or higher. You must have started treatment with either clindamycin alone or a combination of clindamycin and rifampicin. A laboratory test must show that your infection is caused by a type of bacteria called Staphylococcus that is sensitive to both clindamycin and rifampicin. You will need to be admitted to a hospital ward specializing in bone injuries, trauma, or skin conditions. If you are able to have children, you must use highly effective birth control methods during the trial.

Who cannot participate: Unfortunately, despite the trial's focus on infections, people with certain types of infections cannot take part. Specifically, if you have an infection related to a broken bone, a chronic skin condition called hidradenitis suppurativa, or an infection in an artificial joint replacement, you are not eligible for this study. Additionally, people who belong to vulnerable populations, such as those unable to provide informed consent, cannot participate.

Investigational drugs: The trial uses two main antibiotics. Clindamycin is an established antibiotic that works by stopping bacteria from making proteins they need to grow and multiply. It is used to treat various types of infections and can be given by mouth or through a vein. Rifampicin is another antibiotic commonly used to treat serious infections, including tuberculosis. In this study, researchers want to see if taking rifampicin affects how the body processes clindamycin and whether the combination is more effective than clindamycin alone.