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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-sternotomy wound infection and/or mediastinits | Patients with post-sternotomy wound infection and/or mediastinits |
| |
| Prosthetic joint infections | Patients with prosthetic joint infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delafloxacin | Drug | Delafloxacin administered as treating physicians' choice for skin and soft tissue infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delafloxacin concentration | Plasma concentration of delafloxacin Concentration of delafloxacin in tissues:
| 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. |
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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
Exclusion criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Ripa, MD | Contact | +390226433646 | ripa.marco@hsr.it | |
| Elisabetta Carini | Contact | +390226437939 | carini.elisabetta@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Ripa, MD | IRCCS San Raffaele Scientific Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| D008480 | Mediastinitis |
| D010019 | Osteomyelitis |
| D001170 | Arthritis, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C477891 | delafloxacin |
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| D001850 |
| Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |