This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation.
The main objectives of this study are:
* Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation. * Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation. * Evaluation of the pharmacokinetics (in whole blood) of the drug Fluorothiazinone with a single daily dose of 2400 mg/day.
Researchers will compare results for the treatment and the placebo arms.
Patient's written consent to participate in the study in accordance with the current legislation or the decision of the board in case of absence of consciousness of the patient.
Patients are at least 18 years old, male and female.
Patients who are in the ICU (intensive care unit).
SpO2 (peripheral oxygen saturation) ≤ 93%;
The patient was not switched to ALV within 72 hours (3 days) after receiving the investigational drug.
People who have a bloodstream infection, identified during the screening.
A patient may terminate his/her participation in the study at any time for any reason and without any explanation.
Refusal of the patient to participate in the study;
Parallel
Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day
DrugTreatment arm patients will receive Fluorothiazinone, tablets 300 mg at a dose: * 2400 mg/day (4 tablets twice a day) for the first 2 days and; * 1800 mg/day (3 tablets twice a day) from the third day and further (but no more than 14 days) until the occurrence of ventilator-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, OR the completion of the patient's participation in the study for other reasons. Tablets are taken 2 times a day 12 hours apart 30 minutes after meal, no more than 14 days.
Placebo
Other interventionPlacebo arm patients will receive placebo: * 4 tablets twice a day for the first 2 days and; * 3 tablets twice a day and further (but no more than 14 days) until the occurrence of ventilator-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, OR the completion of the patient's participation in the study for other reasons. Tablets are taken 2 times a day 12 hours apart 30 minutes after meal, no more than 14 days.
MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV)
The proportion of patients in the study groups without clinically and microbiologically confirmed MV-associated pneumonia caused by gram-negative bacteria, which developed no earlier than 72 hours (3 days) and no later than 120 hours (5 days) from the moment of tracheal intubation and the start of the MV, in the absence of signs of pulmonary infection at the time of intubation.
Time from the beginning of the MV to the development of MV-associated pneumonia
The time from the beginning of the MV to the development of MV-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, in the study groups during the entire period of therapy.
Time from the beginning of the MV to the development of a bloodstream infection
The time from the beginning of the MV to the development of a bloodstream infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy.
Time from the beginning of the MV to the development of urinary tract infection
The time from the beginning of the MV to the development of urinary tract infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy.
Proportion of patients who developed urinary tract infection
The proportion of patients who developed urinary tract infection caused by gram-negative bacteria, confirmed microbiologically, in the study groups during the entire period of reception of the investigative drug (IMP).
Comparative characteristics of colonization of the respiratory and urinary tracts
Comparative characteristics of colonization of the respiratory and urinary tracts by individual pathogens in patients on the MV.
Comparative assessment of the condition on the SOFA scale
Comparative assessment of the condition on the Sequential Organ Failure Assessment (SOFA) scale. Comparative assessment of the condition on the SOFA scale throughout the study. Score ranges from 0 (best) to 24 (worst) points.
Comparative assessment of the condition on the APACHE II scale
Comparative assessment of the condition on the Acute Physiology and Chronic Health Evaluation II (APACHE II) scale throughout the study. Calculates an integer score from 0 to 71 based on multiple measurements. Higher scores correspond to more severe disease and a higher risk of death.
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