Perioperative SDD to Prevent Infectious Complications After Esophagectomy

PHASE3RecruitingINTERVENTIONAL
Enrollment

854

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

June 30, 2028

Conditions
Esophageal Cancer
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."

Trial Locations (2)

3000

RECRUITING

UZ Leuven, Leuven

6525GA

RECRUITING

Radboudumc, Nijmegen

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

lead

Radboud University Medical Center

OTHER