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

NCT07426471 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-23

No results posted yet for this study

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

Interventions

DRUG

delafloxacin

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

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Marco Ripa, MD · IRCCS San Raffaele Scientific Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426471 on ClinicalTrials.gov