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Antibiotic penetration study aims to improve infection treatment

NCT ID NCT07426471

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the antibiotic delafloxacin spreads through the body in 20 adults with serious skin, soft tissue, bone, or joint infections. Researchers will measure drug levels in blood and in tissues collected during surgery. The goal is to understand if the drug reaches infected areas effectively and how patient factors like age or kidney function affect its levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial arthritis mediastinitis osteomyelitis periprosthetic joint infection skin disease caused by bacterial infection Soft Tissue Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mediastinitis Osteomyelitis/septic arthritis Prosthetic-joint infection Soft tissue infections

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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