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

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.

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Key information

Conditions

Soft Tissue Infections Arthritis Arthritis, Infectious Bone Diseases Bone Diseases, Infectious Infections Joint Diseases Mediastinal Diseases Mediastinitis Musculoskeletal Diseases Osteomyelitis Osteomyelitis/Septic Arthritis Prosthetic Joint Infection Respiratory Tract Diseases Thoracic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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).

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

Treatment and study plan

Delafloxacin

Drug

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

Primary outcomes

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabetta Carini

CONTACT

[email protected]

+390226437939

Marco Ripa, MD

CONTACT

[email protected]

+390226433646

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: DELA-PLAT

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Feb 23, 2026
Registry last updated: Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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