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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator |
| |
| Antiseptic (Octenisept) group | Active Comparator |
| |
| Bacteriophage (Sextaphag) group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Drug | Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation |
|
| 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 |
| 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 |
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Inclusion Criteria:
- invasive mechanical ventilation beyond 48 hours
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2" | Severodvinsk | Arkhangelskaya oblast | 164500 | Russia |
All IPD that underlie results in a publication
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| Antiseptic Solution | Drug | Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation |
|
|
| Bacteriophage | Drug | Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation |
|
|
| 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 |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D001930 | Brain Injuries |
| D059413 | Intraabdominal Infections |
| D010195 | Pancreatitis |
| D008581 | Meningitis |
| D004660 | Encephalitis |
| D012640 | Seizures |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D007239 | Infections |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C000718682 | octenidine and phenoxyethanol drug combination |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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