Soft Tissue InfectionsDELA-PLATNCT07426471
Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.
An observational study of Soft Tissue Infections and Mediastinitis, run by IRCCS San Raffaele.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Infections, Mediastinitis, Osteomyelitis/Septic Arthritis
- What is being tested?
- delafloxacin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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:
Read more
- 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
- Being tested
- delafloxacin
- Medical subject headings
- Soft Tissue Infections, Mediastinitis, Osteomyelitis, Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delafloxacinDrug
Delafloxacin administered as treating physicians' choice for skin and soft tissue infection
| Study group | Role | What they receive |
|---|---|---|
| Post-sternotomy wound infection and/or mediastinits | Patients with post-sternotomy wound infection and/or mediastinits Receives: Drug: delafloxacin | |
| Prosthetic joint infections | Patients with prosthetic joint infections Receives: Drug: delafloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delafloxacin concentration
Plasma concentration of delafloxacin
Concentration of delafloxacin in tissues:
- soft tissue
- periprosthetic tissue
- synovial fluid
- bone (cancellous and cortical)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InfectionsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Castagna Antonella, IRCCS San Raffaele
- Investigators
- Marco Ripa, MD, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426471
- Sponsor's protocol ID
- CET 307-202
- Acronym
- DELA-PLAT
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07426471
- Acronym / sponsor ID
- DELA-PLAT / CET 307-202
- Conditions
- Soft Tissue Infections, Mediastinitis, Osteomyelitis/Septic Arthritis, Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-sternotomy wound infection and/or mediastinits | – | Drug: delafloxacinPatients with post-sternotomy wound infection and/or mediastinits |
| Prosthetic joint infections | – | Drug: delafloxacinPatients with prosthetic joint infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delafloxacinDelafloxacin administered as treating physicians' choice for skin and soft tissue infection | Drug | Post-sternotomy wound infection and/or mediastinits, Prosthetic joint infections |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Ripa, MD principal investigator
IRCCS San Raffaele Scientific Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Infections and Mediastinitis, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Ripa, MD (+390226433646, ripa.marco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.