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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325685
Recruitment Status : Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Vsevolod V. Kuzkov, Northern State Medical University

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).

Condition or disease Intervention/treatment Phase
Trauma Injury Brain Injuries Abdominal Sepsis Pancreatitis Meningitis Encephalitis Seizures Acute Respiratory Distress Syndrome Drug: Control Drug: Antiseptic Solution Drug: Bacteriophage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Placebo Comparator: Control group Drug: Control
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
Other Name: Saline

Active Comparator: Antiseptic (Octenisept) group Drug: Antiseptic Solution
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
Other Name: Octenisept

Experimental: Bacteriophage (Sextaphag) group Drug: Bacteriophage
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
Other Name: Sextaphag




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325685


Locations
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Russian Federation
Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
Severodvinsk, Arkhangelsk Region, Russian Federation, 164500
Sponsors and Collaborators
Northern State Medical University
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Responsible Party: Vsevolod V. Kuzkov, Principal investigator, Northern State Medical University
ClinicalTrials.gov Identifier: NCT04325685    
Other Study ID Numbers: SGDC-VAP-1
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pancreatitis
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Brain Injuries
Seizures
Meningitis
Encephalitis
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurologic Manifestations
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Injury
Cross Infection
Infection
Anti-Infective Agents, Local
Octenidine