drugset / Trial / NCT04839653

Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria

NCT04839653

Unknown 60 enrolled MEDSI Clinical Hospital 1, ICU
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Secondary infections remain a major cause of mortality in critically ill patients, mainly because of high prevalence of multidrug-resistant microorganisms. Therefore strategies aimed to reduce the incidence of ventilator-associated pneumoniae (VAP) and bloodstream infections are of utmost important. There is robust data on selective digestive decontamination (SDD) efficacy in reduction of secondary infections in intensive care units (ICU) with low rates of antibacterial resistance. However the data received from hospitals with moderate-to-high rates of resistance is equivocal. This as an interventional parallel open-label study investigating the effect of selective digestive decontamination on the rates of ventilator-associated pneumonia in critically ill patients admitted to the ICU with high prevalence of drug-resistant bacteria. Secondary outcomes include rates of bloodstream infections, mortality, duration of mechanical ventilation, duration of ICU stay, resistance selection and overall antibiotic consumption.

Timeline

Start
2021-05-01
Primary completion
2022-04
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericine B Unknown 150 mg Topical
Subject Amphotericine B Unknown 350 mg Topical
Subject Cefotaxime Small molecule 1 g Intravenous
Subject Ceftriaxone Other / unclassified 1 g Intravenous
Subject Gentamicin Small molecule 10 mg Topical
Subject Gentamicin Small molecule 80 mg Topical
Subject Polymyxin B Peptide 10 mg Topical
Subject Polymyxin B Peptide 100 mg Topical
Subject Vancomycin Other / unclassified 500 mg Other
Subject nistatin Unknown 500000 iu Topical
Subject nistatin Unknown 8e+06 iu Topical