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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
* Age ≥ 18 years,
* Able to give written informed consent.
Exclusion Criteria:
* Patients planned for rescue surgery,
* Patients planned for colonic interposition,
* Known or suspected pregnancy,
* Patients who have undergone upper GI surgery within 30 days before randomization,
* Unable to understand the study information, study instructions and give informed consent.
* Patients enrolled in a trial that would interact with the intervention
* Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
* Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
* Patients undergoing CVVH.
* Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
* Women of childbearing potential at risk of pregnancy, not using adequate contraception,
* Patients with the inability to swallow the SDD
* Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).
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
More Radboud University Medical Center trials in Belgium
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.
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