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RECRUITING
NCT05865743
PHASE3

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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

Official title: PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients with Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

854

Start Date

2024-10-21

Completion Date

2028-06-30

Last Updated

2025-03-05

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (2)

UZ Leuven

Leuven, Belgium

Radboudumc

Nijmegen, Netherlands