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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with expected MV for more than 24 hours

Locations
Other Locations
Russian Federation
MEDSI Clinical Hospital 1
RECRUITING
Moscow
Contact Information
Primary
Yury Surovoy, MD
ysurovoy@gmail.com
+79166911507
Backup
Armen Oganesyan, MD
oganesyan.av@medsigroup.ru
Time Frame
Start Date: 2021-05-01
Completion Date: 2023-04
Participants
Target number of participants: 60
Treatments
No_intervention: Control group: standard care
Patients in the standard care group will be prospectively evaluated to determine pre-defined clinical outcomes.
Experimental: Selective digestive decontamination group
1. Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B q6h~2. In the NGT 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B and 500 mg of vancomycin q6h~3. A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd
Related Therapeutic Areas
Sponsors
Leads: MEDSI Clinical Hospital 1, ICU

This content was sourced from clinicaltrials.gov