Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

PHASE2RecruitingINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

November 6, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Gram Negative PneumoniaGram-Negative Bacterial InfectionsBacteremia Caused by Gram-Negative Bacteria
Interventions
DRUG

Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day

"Treatment 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."

OTHER

Placebo

"Placebo 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."

Trial Locations (2)

119049

RECRUITING

State Budgetary Healthcare Institution of Moscow City Clinical Hospital No. 1 named after N.I. Pirogov of the Moscow Department of Health (State Clinical Hospital No. 1 named after N.I. Pirogov), Moscow

127015

RECRUITING

City Clinical Hospital No. 24 of the Moscow City Department of Health, Moscow

All Listed Sponsors
lead

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

OTHER