Ireland
--:--IST
Recruiting Phase 3

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

NCT05865743 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 3
Started
2024-10-21
Last updated
2025-03-05

Condition(s) studied

Esophageal Cancer

Investigational drug(s) / intervention(s)

SDD

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)

FacilityCityRegionStatus
UZ Leuven Leuven Belgium Recruiting
Radboudumc Nijmegen Netherlands Recruiting
Official registry record

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