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;
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Lead sponsor