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

Northern State Medical University

Status: Completed

Conditions: Seizures; Brain Injuries; Meningitis; Trauma Injury; Encephalitis; Abdominal Sepsis; Acute Respiratory Distress Syndrome; Pancreatitis

Treatments: Drug: Bacteriophage; Drug: Antiseptic Solution; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04325685

SGDC-VAP-1

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• invasive mechanical ventilation beyond 48 hours

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Treatment:

Drug: Control

Antiseptic (Octenisept) group

Active Comparator group

Treatment:

Drug: Antiseptic Solution

Bacteriophage (Sextaphag) group

Experimental group

Treatment:

Drug: Bacteriophage