- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325685
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia (SGDC-VAP)
November 7, 2023 updated by: Vsevolod V. Kuzkov, Northern State Medical University
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Konstantin Lapin
- Phone Number: +7 960 - 006 - 15 - 87
- Email: Lapin18151@gmail.com
Study Contact Backup
- Name: Vsevolod Kuzkov, PhD, MD
- Email: v_kuzkov@mail.ru
Study Locations
-
-
Arkhangelsk Region
-
Severodvinsk, Arkhangelsk Region, Russian Federation, 164500
- Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- invasive mechanical ventilation beyond 48 hours
Exclusion Criteria:
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
- reintubation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
|
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
Other Names:
|
Active Comparator: Antiseptic (Octenisept) group
|
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
Other Names:
|
Experimental: Bacteriophage (Sextaphag) group
|
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline CPIS at 14 days
|
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
|
Change from Baseline Microbiology researching at 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline Sequential Organ Function Assessment at 14 days
|
Concentration of C - reactive protein (CRP)
Time Frame: Change from Baseline CRP at 14 days
|
Biomarker of the VAP
|
Change from Baseline CRP at 14 days
|
Concentration of Procalcitonin (PCT)
Time Frame: Change from Baseline PCT at 14 days
|
Biomarker of the VAP
|
Change from Baseline PCT at 14 days
|
Rate of Mortality
Time Frame: Change from Baseline PCT at 28 days
|
Mortality for 28 days of a hospitalization
|
Change from Baseline PCT at 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
November 7, 2023
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Neurologic Manifestations
- Disease Attributes
- Infant, Newborn, Diseases
- Cross Infection
- Iatrogenic Disease
- Craniocerebral Trauma
- Trauma, Nervous System
- Pancreatic Diseases
- Lung Injury
- Infant, Premature, Diseases
- Healthcare-Associated Pneumonia
- Neuroinflammatory Diseases
- Encephalitis
- Brain Injuries
- Pneumonia
- Wounds and Injuries
- Intraabdominal Infections
- Seizures
- Meningitis
- Pancreatitis
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Pneumonia, Ventilator-Associated
- Anti-Infective Agents
- Anti-Infective Agents, Local
Other Study ID Numbers
- SGDC-VAP-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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