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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDSI Clinical Hospital 1, ICU
• Treatments: Amphotericin B; Anti-Bacterial Agents; Cefotaxime; Cefoxitin; Ceftriaxone; Gentamicins; Liposomal amphotericin B; Polymyxin B; Polymyxins; Vancomycin

Criteria

Inclusion Criteria:

• Patients with expected MV for more than 24 hours

Exclusion Criteria:

• Moribund condition and expected death within 24 hours

• Malignancy (excluding primary CNS tumors)

• Patients transferred from other hospitals who were mechanically ventilated for more than 24 hours (including NIV)