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

Acute Respiratory Distress Syndrome Clinical Trial

— SGDC-VAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325685
• Other study ID #: SGDC-VAP-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 7, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abdominal Sepsis
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Brain Injuries
• Encephalitis
• Intraabdominal Infections
• Meningitis
• Pancreatitis
• Pneumonia
• Pneumonia, Ventilator-Associated
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Seizures
• Trauma Injury
• Wounds and Injuries

Intervention

Drug:
• Control
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
• Antiseptic Solution
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
• Bacteriophage
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Locations

Country	Name	City	State
Russian Federation	Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"	Severodvinsk	Arkhangelsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Concentration of C - reactive protein (CRP)	Biomarker of the VAP	Change from Baseline CRP at 14 days
Secondary	Concentration of Procalcitonin (PCT)	Biomarker of the VAP	Change from Baseline PCT at 14 days
Secondary	Rate of Mortality	Mortality for 28 days of a hospitalization	Change from Baseline PCT at 28 days