Determination of a Trough Serum Concentration of Ofloxacin Associated with Increased Side Effects Frequency in Elderly Patients Treated for Bone and Joint Infection

What this Trial Is About

Researchers are studying the relationship between the blood levels of ofloxacin, an antibiotic used to treat bone and joint infections caused by sensitive staphylococcus strains, and the occurrence of side effects in elderly patients. The study focuses on patients aged 65 and older, as variations in how the drug is processed in the body may affect its safety and effectiveness. The goal is to find if higher ofloxacin concentrations in the blood increase the chance of adverse effects and to identify a threshold concentration linked to toxicity. Participants will receive ofloxacin as part of their treatment for bone and joint infections. The study involves measuring the serum concentration of ofloxacin on day 3 (both minimum and maximum levels), day 21, and day 42 (minimum levels). Additionally, clinicians will complete questionnaires about any ofloxacin side effects on days 3, 21, and 42 to monitor patient reactions during and after treatment. During the study, patients will be closely monitored with blood tests to measure ofloxacin levels and regular side effect assessments through questionnaires. The main outcome measured is the frequency of at least one adverse reaction attributed to ofloxacin by day 3. Participation involves follow-up visits up to day 42 for ongoing evaluation. The study is sponsored by Centre Hospitalier Universitaire, Amiens, and aims to improve understanding of ofloxacin safety in the elderly.

Ofloxacin Concentration-toxicity Relationship in the Elderly