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

Recruiting Phase 2 Interventional Study
Gram Negative Pneumonia Gram-Negative Bacterial Infections Bacteremia Caused by Gram-Negative Bacteria
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
234 (estimated)
Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Other
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About This Trial
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 com…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Patients are at least 18 years old, male and female. 3. Patients who are in the ICU (intensive …
Contacts

Nailya A. Zigangirova, Doctor of Biological Sciences

+7 (499) 193-30-01

zigangirova@mail.ru

CONTACT