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

NCT04839653 | Unknown

• 1 other identifier: SDDMEDSI2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia, Ventilator-Associated; Pneumonia; Bloodstream Infection; Sepsis; Respiratory Distress Syndrome; Respiratory Tract Infections; Critical Illness

Keywords

Pneumonia; Ventilator-Associated Pneumonia; Selective Digestive Decontamination; Secondary Infections; Infection prophylaxis; Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• The incidence of ventilator-associated pneumonia

  Number of ventilator-associated pneumonia events per 1000 days of MV

  During ICU stay up to 28 days

Secondary Outcomes (6)

• The incidence of bloodstream infections

  During ICU stay up to 28 days

• ICU mortality

  During ICU stay up to 28 days

• Duration of mechanical ventilation

  During ICU stay up to 28 days

• Duration of organ support

  During ICU stay up to 28 days

• Antimicrobial drug consumption

  During ICU stay up to 28 days

Study Arms (2)

Control group: standard care

NO INTERVENTION

Patients in the standard care group will be prospectively evaluated to determine pre-defined clinical outcomes.

Selective digestive decontamination group

EXPERIMENTAL

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

Drug: Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h; Drug: Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h; Drug: Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd

Interventions

Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h DRUG

The oral paste will be applied topically on the oropharyngeal mucosa q6h.

Also known as: Polymyxin B, Gentamycin, Amphotericine B, Nistatin

Selective digestive decontamination group

Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h DRUG

The suspension will be administered through the nasogastric tube q6h.

Also known as: Polymyxin B, Gentamycin, Amphotericine B, Vancomycine, Nistatin

Selective digestive decontamination group

Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd DRUG

Patients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic

Also known as: Cefotaxime, Ceftriaxone

Selective digestive decontamination group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with expected MV for more than 24 hours

You may not qualify if:

• 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)

Sponsors & Collaborators

• MEDSI Clinical Hospital 1, ICU: lead

Study Sites (1)

MEDSI Clinical Hospital 1

Moscow, 143442, Russia

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia; Sepsis; Respiratory Distress Syndrome; Respiratory Tract Infections; Critical Illness; Coinfection

Interventions

Polymyxin B; Gentamicins; Suspensions; Vancomycin; Ceftriaxone; Cefotaxime

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Aminoglycosides; Glycosides; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Glycopeptides; Glycoconjugates; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dmitry Azovskiy, MD, phD

  MEDSI Clinical Hospital 1

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yury Surovoy, MD

CONTACT

+79166911507; ysurovoy@gmail.com

Armen Oganesyan, MD

CONTACT

oganesyan.av@medsigroup.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: During the first period patients will receive standard care. During the second period SDD protocol will be implemented.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: May 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

RU (1)