The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia (SGDC-VAP)

The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Encephalitis; Seizures; Trauma Injury; Meningitis; Pancreatitis; Acute Respiratory Distress Syndrome; Abdominal Sepsis
• Intervention / Treatment: Drug: Control; Drug: Antiseptic Solution; Drug: Bacteriophage

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk Region
    • Severodvinsk, Arkhangelsk Region, Russian Federation, 164500
      • Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

• hospital - acquired pneumonia
• community - acquired pneumoniae
• BMI > 35 kg/cm2
• pregnancy
• tracheostomy
• reintubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Drug: Control; Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation; Other Names: Saline
Active Comparator: Antiseptic (Octenisept) group	Drug: Antiseptic Solution; Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation; Other Names: Octenisept
Experimental: Bacteriophage (Sextaphag) group	Drug: Bacteriophage; Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation; Other Names: Sextaphag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ventilator-associated pneumonia (VAP)	CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed	Change from Baseline CPIS at 14 days
Changing of oral and lung microbiomes	Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit	Change from Baseline Microbiology researching at 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ dysfunction	Sequential Organ Function Assessment (SOFA) will be using for assessment organ dysfunction Patient examination with Sequential Organ Function Assessment (SOFA). If Sequential Organ Function Assessment more then 2 points Organ dysfunction is present. The hirher value is equal worse outcome	Change from Baseline Sequential Organ Function Assessment at 14 days
Concentration of C - reactive protein (CRP)	Biomarker of the VAP	Change from Baseline CRP at 14 days
Concentration of Procalcitonin (PCT)	Biomarker of the VAP	Change from Baseline PCT at 14 days
Rate of Mortality	Mortality for 28 days of a hospitalization	Change from Baseline PCT at 28 days

Collaborators and Investigators

• Sponsor: Northern State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Neurologic Manifestations; Disease Attributes; Infant, Newborn, Diseases; Cross Infection; Iatrogenic Disease; Craniocerebral Trauma; Trauma, Nervous System; Pancreatic Diseases; Lung Injury; Infant, Premature, Diseases; Healthcare-Associated Pneumonia; Neuroinflammatory Diseases; Encephalitis; Brain Injuries; Pneumonia; Wounds and Injuries; Intraabdominal Infections; Seizures; Meningitis; Pancreatitis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Infective Agents, Local
• Other Study ID Numbers: SGDC-VAP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No