Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. (DELA-PLAT)

February 20, 2026 updated by: Castagna Antonella, IRCCS San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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

    1. post-sternotomy wound infection and/or mediastinitis undergoing surgical debridement
    2. 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).

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-sternotomy wound infection and/or mediastinits
Patients with post-sternotomy wound infection and/or mediastinits
Drug: delafloxacin
Delafloxacin administered as treating physicians' choice for skin and soft tissue infection
Prosthetic joint infections
Patients with prosthetic joint infections
Drug: delafloxacin
Delafloxacin administered as treating physicians' choice for skin and soft tissue infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delafloxacin concentration
Time Frame: 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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Marco Ripa, MD, IRCCS San Raffaele Scientific Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET 307-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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