Actively Recruiting
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
Led by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Updated on 2025-06-24
234
Participants Needed
2
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient's written consent to participate in the study or decision by board if patient unconscious
- Patients aged 18 years or older, male or female
- Patients currently in the intensive care unit (ICU)
- Patients with laboratory confirmed SARS-CoV-2 infection and severe community-acquired pneumonia requiring ICU care with respiratory failure symptoms, OR acute stroke, OR acute heart failure including cardiogenic shock, pulmonary edema, or acute decompensated chronic heart failure
- Patients on artificial lung ventilation (ALV) for no more than 12 hours
- Patients assessed by investigator as high risk of needing ALV within 72 hours of therapy start
- Women of childbearing age and men with partners of childbearing age must agree to use effective contraception during the study
You will not qualify if you...
- Patient not switched to artificial lung ventilation within 72 hours after starting the investigational drug
- Presence of bloodstream infection detected during screening
- Patient chooses to withdraw from the study at any time for any reason
- Investigator may withdraw patient if required by patient's condition
- Sponsor or regulator may terminate the trial early for safety or conduct reasons
- Development of adverse events or serious adverse events preventing further participation
- Occurrence or worsening of other diseases not related to the investigational drug at investigator's discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
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, 119049
Actively Recruiting
2
City Clinical Hospital No. 24 of the Moscow City Department of Health
Moscow, Moscow, Russia, 127015
Actively Recruiting
Research Team
N
Nailya A. Zigangirova, Doctor of Biological Sciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here