Study of Fluorothiazinones Safety and Effectiveness to Prevent Hospital Bacterial Infections in Patients on Mechanical Ventilation

What this Trial Is About

Researchers are evaluating the clinical and antibacterial effects, safety, and pharmacokinetics of the drug Fluorothiazinone compared to a placebo for preventing hospital-acquired gram-negative bacterial infections in patients who are on mechanical ventilation. The study is a randomized, double-blind, placebo-controlled clinical trial conducted by the Gamaleya Research Institute of Epidemiology and Microbiology. Participants are randomly assigned to receive either Fluorothiazinone tablets or a matching placebo. Those in the treatment group take 2400 mg per day 4 tablets twice daily for the first two days, then 1800 mg per day 3 tablets twice daily from day three onward for up to 14 days or until ventilator-associated pneumonia caused by gram-negative bacteria develops. Tablets are taken twice daily, 12 hours apart, 30 minutes after meals. The placebo group follows the same dosing schedule with inactive tablets. During the study, participants are monitored for the development of pneumonia, bloodstream infections, and urinary tract infections associated with mechanical ventilation over a 14-day therapy period. Researchers track the time to infection onset, the proportion of patients affected by infections or septic complications, and any fatal outcomes. Safety, tolerability, and blood levels of Fluorothiazinone are also evaluated. The study includes adult patients in intensive care units who have been on mechanical ventilation for no more than 12 hours and are at high risk of requiring ventilation within 72 hours.

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