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

Primary Purpose

Trauma Injury, Brain Injuries, Abdominal Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Control
Antiseptic Solution
Bacteriophage
Sponsored by
Northern State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Sites / Locations

  • Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Control group

Antiseptic (Octenisept) group

Bacteriophage (Sextaphag) group

Arm Description

Outcomes

Primary Outcome Measures

Incidence of ventilator-associated pneumonia (VAP)
CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed
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

Secondary Outcome Measures

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
Concentration of C - reactive protein (CRP)
Biomarker of the VAP
Concentration of Procalcitonin (PCT)
Biomarker of the VAP
Rate of Mortality
Mortality for 28 days of a hospitalization

Full Information

First Posted
March 26, 2020
Last Updated
April 7, 2022
Sponsor
Northern State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04325685
Brief Title
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia
Acronym
SGDC-VAP
Official Title
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury, Brain Injuries, Abdominal Sepsis, Pancreatitis, Meningitis, Encephalitis, Seizures, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Antiseptic (Octenisept) group
Arm Type
Active Comparator
Arm Title
Bacteriophage (Sextaphag) group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Saline
Intervention Description
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
Intervention Type
Drug
Intervention Name(s)
Antiseptic Solution
Other Intervention Name(s)
Octenisept
Intervention Description
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
Intervention Type
Drug
Intervention Name(s)
Bacteriophage
Other Intervention Name(s)
Sextaphag
Intervention Description
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
Primary Outcome Measure Information:
Title
Incidence of ventilator-associated pneumonia (VAP)
Description
CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed
Time Frame
Change from Baseline CPIS at 14 days
Title
Changing of oral and lung microbiomes
Description
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
Time Frame
Change from Baseline Microbiology researching at 14 days
Secondary Outcome Measure Information:
Title
Organ dysfunction
Description
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
Time Frame
Change from Baseline Sequential Organ Function Assessment at 14 days
Title
Concentration of C - reactive protein (CRP)
Description
Biomarker of the VAP
Time Frame
Change from Baseline CRP at 14 days
Title
Concentration of Procalcitonin (PCT)
Description
Biomarker of the VAP
Time Frame
Change from Baseline PCT at 14 days
Title
Rate of Mortality
Description
Mortality for 28 days of a hospitalization
Time Frame
Change from Baseline PCT at 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - invasive mechanical ventilation beyond 48 hours Exclusion Criteria: hospital - acquired pneumonia community - acquired pneumoniae BMI > 35 kg/cm2 pregnancy tracheostomy reintubation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantin Lapin
Phone
960 - 006 - 15 - 87
Ext
+7
Email
Lapin18151@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vsevolod Kuzkov, PhD, MD
Email
v_kuzkov@mail.ru
Facility Information:
Facility Name
Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
City
Severodvinsk
State/Province
Arkhangelsk Region
ZIP/Postal Code
164500
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Lapin
Phone
960-006-15-87
Ext
+7
Email
Lapin18151@gmail.com
First Name & Middle Initial & Last Name & Degree
Vsevolod Kuzkov, PhD, MD
Email
v_kuzkov@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication

Learn more about this trial

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

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