Antibiotic penetration study aims to improve infection treatment
NCT ID NCT07426471
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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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A doctor treating you
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