Perioperative SDD to Prevent Infectious Complications After Esophagectomy
Condition(s) studied
Investigational drug(s) / intervention(s)
SDD: The intervention group receives SDD treatment additional to standard care, comprising two distinct liquids for oral administration: first the 5 ml amphotericin B suspension (100 mg/ml) and subsequently the 5 ml "SDD base for suspension", containing both colistin sulphate (20 mg/ml) and tobramycin sulphate (16 mg/ml). Patients take the 5 ml amphotericin B, followed by the 5 ml "SDD base for suspension", four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose.
Study summary
The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia
Eligibility
Primary outcome measure(s)
- the cumulative incidence of postoperative pneumonia within 30 days after surgery — Within 30 days after surgery
The primary outcome parameter is the cumulative incidence of postoperative pneumonia within 30 days after surgery. Pneumonia will be defined by the following criteria: * Positive sputum culture OR * Presence of a new progressive radiographic infiltrate plus at least 2 of the following clinical features: * Fever \> 38.5°C * Leukocytosis (\>11.0) or leukopenia (\<4.0) * Purulent secretions
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Recruiting |
| Radboudumc | Nijmegen | Netherlands | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05865743 on ClinicalTrials.gov ↗ ← All trials in the Netherlands