A Randomized, Double-blind, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of the Drug Fluorothiazinone (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on Mechanical Ventilation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• Patients with:

‣ 1. Laboratory confirmed SARS-CoV-2 (Severe acute respiratory syndrome-related coronavirus-2) on screening (a patient's coronavirus infection can be confirmed either before admission to the hospital (for outpatient treatment) or when admitted to the hospital) by RT-PCR (reverse transcription polymerase chain reaction) AND severe community-acquired pneumonia in ICU with evidence of viral lung injury and symptoms of respiratory failure:

⁃ SpO2 (peripheral oxygen saturation) ≤ 93%;

⁃ Lung changes of 3rd- to 4th-degree according to CT (results of computed tomography), consistent with viral involvement; OR 4.2. Acute stroke; OR 4.3. Acute heart failure: Cardiogenic shock of any cause, pulmonary edema, or acute decompensated chronic heart failure.

• Patients who have been on ALV (artificial lung ventilation) for no more than 12 hours.

• Patients who are according to the investigator are at high risk to be transferred to ALV within 72 hours of the initiation of the therapy.

• All women of childbearing age and men with partners of childbearing age should agree to use an effective contraceptive methods (e.g., implants, infections, combination oral contraceptives, intrauterine device, abstinence, vasectomy or vasectomy partner) during the entire study.

Locations
Other Locations
Russian Federation
City Clinical Hospital No. 24 of the Moscow City Department of Health
RECRUITING
Moscow
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)
RECRUITING
Moscow
Contact Information
Primary
Nailya A. Zigangirova, Doctor of Biological Sciences
zigangirova@mail.ru
+7 (499) 193-30-01
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 234
Treatments
Experimental: Treatment arm
Placebo_comparator: Placebo arm
Related Therapeutic Areas
Sponsors
Leads: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

This content was sourced from clinicaltrials.gov

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