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

NCT07426471 | Not Yet Recruiting

• 1 other identifier: CET 307-202
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Soft Tissue Infections; Mediastinitis; Osteomyelitis/Septic Arthritis; Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Delafloxacin concentration

  Plasma concentration of delafloxacin Concentration of delafloxacin in tissues: * soft tissue * periprosthetic tissue * synovial fluid * bone (cancellous and cortical)

  Peripheral blood samples drawn at 15 minutes, 1 hour, 3 hours, 5-7 hours, 11 hours after the end of delafloxacin infusion (delafloxacin infusion lasts approximately 1 hour). Tissue samples obtained according to patient's surgical plan.

Study Arms (2)

Post-sternotomy wound infection and/or mediastinits

Patients with post-sternotomy wound infection and/or mediastinits

Drug: delafloxacin

Prosthetic joint infections

Patients with prosthetic joint infections

Drug: delafloxacin

Interventions

delafloxacin DRUG

Delafloxacin administered as treating physicians' choice for skin and soft tissue infection

Post-sternotomy wound infection and/or mediastinits; Prosthetic joint infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital receiving delafloxacin according to treating physician's choice and good clinical practice or available guidelines with bacterial skin and skin structure infection and with: 1\) post-sternotomy wound infection and/or mediastinitis undergoing surgical debridement or 1\) prosthetic joint infections undergoing surgical debridement or prosthetic joint removal (either one-stage, e.g. when the Infected prosthesis is removed and a new one is implanted in the same surgery, or two-stage, when the Infected prosthesis is removed, followed by a period of antibiotics, then a new prosthesis is implanted in a second surgery).

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study, and to be concurrently enrolled in the Institutional Infectious Disease Biobank (INDI-REBIO, NCT06418048)
• \>18 years-old
• eGFR of \> 80 mL/min/1,73m2
• Receiving delafloxacin 300mg q12h IV according to treating physician's choice and good clinical practice or available guidelines with bacterial skin and skin structure infection and with
• post-sternotomy wound infection and/or mediastinitis undergoing surgical debridement
• prosthetic joint infections undergoing surgical debridement or prosthetic joint removal (either one-stage, e.g. when the Infected prosthesis is removed and a new one is implanted in the same surgery, or two-stage, when the Infected prosthesis is removed, followed by a period of antibiotics, then a new prosthesis is implanted in a second surgery).

You may not qualify if:

• Patients who received other quinolones (oral or IV) in the week preceding the sample collection
• Patients who decline or are unwilling to participate in serial blood draws at all five designated time points.
• Pregnant or lactating women

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Soft Tissue Infections; Mediastinitis; Osteomyelitis; Arthritis, Infectious

Interventions

delafloxacin

Condition Hierarchy (Ancestors)

Infections; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Marco Ripa, MD

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Ripa, MD

CONTACT

+390226433646; ripa.marco@hsr.it

Elisabetta Carini

CONTACT

+390226437939; carini.elisabetta@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share