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

NCT04325685 | Completed

• 1 other identifier: SGDC-VAP-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Trauma Injury; Brain Injuries; Abdominal Sepsis; Pancreatitis; Meningitis; Encephalitis; Seizures; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Organ dysfunction

  Change from Baseline Sequential Organ Function Assessment at 14 days

• Concentration of C - reactive protein (CRP)

  Change from Baseline CRP at 14 days

• Concentration of Procalcitonin (PCT)

  Change from Baseline PCT at 14 days

• Rate of Mortality

  Change from Baseline PCT at 28 days

Study Arms (3)

Control group

PLACEBO COMPARATOR

Drug: Control

Antiseptic (Octenisept) group

ACTIVE COMPARATOR

Drug: Antiseptic Solution

Bacteriophage (Sextaphag) group

EXPERIMENTAL

Drug: Bacteriophage

Interventions

Control DRUG

Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation

Also known as: Saline

Control group

Antiseptic Solution DRUG

Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation

Also known as: Octenisept

Antiseptic (Octenisept) group

Bacteriophage DRUG

Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Also known as: Sextaphag

Bacteriophage (Sextaphag) group

Eligibility Criteria

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

You may qualify if:

• \- invasive mechanical ventilation beyond 48 hours

You may not qualify if:

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

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

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

Severodvinsk, Arkhangelskaya oblast, 164500, Russia

Location

MeSH Terms

Conditions

Accidental Injuries; Brain Injuries; Intraabdominal Infections; Pancreatitis; Meningitis; Encephalitis; Seizures; Respiratory Distress Syndrome

Interventions

Sodium Chloride; octenidine and phenoxyethanol drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Infections; Pancreatic Diseases; Digestive System Diseases; Neuroinflammatory Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: November 7, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RU (1)