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

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Drug: Control
* Drug: Antiseptic Solution
* Drug: Bacteriophage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - invasive mechanical ventilation beyond 48 hours Exclusion Criteria: hospital - acquired pneumonia community - acquired pneumoniae BMI > 35 kg/cm2 pregnancy tracheostomy reintubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |