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

Not Applicable

Completed

• Conditions: Abdominal Sepsis; Brain Injuries; Pancreatitis; Encephalitis; Acute Respiratory Distress Syndrome; Trauma Injury; Meningitis; Seizures
• Interventions: Drug: Antiseptic Solution; Drug: Control; Drug: Bacteriophage

• Registration Number: NCT04325685
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Primary Completion: 2021-12-31
• Status Verified: 2023-11
• Study Completion: 2023-11-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• invasive mechanical ventilation beyond 48 hours

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiseptic (Octenisept) group	Antiseptic Solution	-
Control group	Control	-
Bacteriophage (Sextaphag) group	Bacteriophage	-

Primary Outcome Measures

Name	Time	Method
Incidence of ventilator-associated pneumonia (VAP)	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
Changing of oral and lung microbiomes	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

Name	Time	Method
Organ dysfunction	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
Concentration of C - reactive protein (CRP)	Change from Baseline CRP at 14 days	Biomarker of the VAP
Rate of Mortality	Change from Baseline PCT at 28 days	Mortality for 28 days of a hospitalization
Concentration of Procalcitonin (PCT)	Change from Baseline PCT at 14 days	Biomarker of the VAP

Trial Locations

Locations (1)

Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"; 🇷🇺 Severodvinsk, Arkhangelsk Region, Russian Federation