Clinical Research Directory

Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.

Sponsor: IRCCS San Raffaele

Summary

The goal of this observational study is to measure how well the antibiotic delafloxacin penetrates into the blood and various body tissues in adult patients over 18 years old. Specifically, this study focuses on patients who are receiving the drug to treat bacterial infections and are undergoing surgery for post-sternotomy wound infections, mediastinitis, or infected prosthetic joints . The main questions it aims to answer are: * What is the concentration of delafloxacin in the blood plasma? * What is the concentration of delafloxacin in different body tissues, including soft tissue, tissue around a prosthetic implant, joint fluid (synovial fluid), and bone ? * How does the concentration of the drug in the blood compare to its concentration in the tissues? * Do patient factors such as age, body weight, and kidney function affect the drug's levels in the body? Participants will: * Continue to receive delafloxacin (300mg intravenously every 12 hours) as prescribed by their treating physician for their infection. * Allow researchers to draw 5 peripheral blood samples (about 10 mL total) at specific times (15 minutes, 1 hour, 3 hours, 5-7 hours, and 11 hours) after the end of a single delafloxacin infusion. * Allow researchers to collect small amounts of tissue and joint fluid for testing during their already planned surgical procedure.

Official title: Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections: a Prospective Mono-center Observational Pharmacological Study.

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