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Simplified Selective Digestive Tract Decontamination for the Prevention of Intensive Care Unit Acquired Infections

NCT01798537 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2013-02-26

No results posted yet for this study

Summary

A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of blood stream infections and to a 25% reduction in lower airway colonization with multi drug resistant organisms. There will be no concomitant rise in gram-positive or fungal infection or a surgency of new resistance patterns.

Conditions

  • Bacteremia Associated With Intravascular Line
  • Ventilator Associated Pneumonia
  • Bacteremia

Interventions

DRUG

Neomycin Colistin Nystatin Vancomycin

All participating study arm patients will receive SDD from admission to discharge

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yaron P Bar-Lavie, M.D. · Rambam Health Care Campus, Haifa, Israel

  • Mical Paul, Prof. · Rambam Health Care Campus, Haifa, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798537 on ClinicalTrials.gov