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NCT Number: NCT04325685

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

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).

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Key information

Conditions

Trauma Injury Abdominal Sepsis Accidental Injuries Acute Respiratory Distress Syndrome Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Digestive System Diseases Encephalitis Infections Intraabdominal Infections Lung Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Pancreatic Diseases Pancreatitis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Seizures Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Severodvinsk, Arkhangelskaya oblast, 164500, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • invasive mechanical ventilation beyond 48 hours

Exclusion criteria

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

Treatment and study plan

Control

Drug

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

Other names: Saline

Antiseptic Solution

Drug

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

Other names: Octenisept

Bacteriophage

Drug

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

Other names: Sextaphag

Primary outcomes

  1. Incidence of ventilator-associated pneumonia (VAP)

    Time frame: Change from Baseline CPIS at 14 days

    CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed

  2. Changing of oral and lung microbiomes

    Time frame: Change from Baseline Microbiology researching at 14 days

    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 outcomes

  1. Organ dysfunction

    Time frame: Change from Baseline Sequential Organ Function Assessment at 14 days

    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

  2. Concentration of C - reactive protein (CRP)

    Time frame: Change from Baseline CRP at 14 days

    Biomarker of the VAP

  3. Concentration of Procalcitonin (PCT)

    Time frame: Change from Baseline PCT at 14 days

    Biomarker of the VAP

  4. Rate of Mortality

    Time frame: Change from Baseline PCT at 28 days

    Mortality for 28 days of a hospitalization

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

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

Acronym: SGDC-VAP

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Mar 27, 2020
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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