Condition: Gram Negative Pneumonia · Gram-Negative Bacterial Infections · Bacteremia Caused by Gram-Negative Bacteria · Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
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.
This description comes directly from the study's public registry record.
Nailya A. Zigangirova, Doctor of Biological Sciences · +7 (499) 193-30-01 · zigangirova@mail.ru
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| 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, Moscow, Russia | Recruiting |
| City Clinical Hospital No. 24 of the Moscow City Department of Health | Moscow, Moscow, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06135350