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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

NCT06135350 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Gram Negative Pneumonia
  • Gram-Negative Bacterial Infections
  • Bacteremia Caused by Gram-Negative Bacteria

Interventions

DRUG

Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day

Treatment arm patients will receive Fluorothiazinone, tablets 300 mg at a dose: * 2400 mg/day (4 tablets twice a day) for the first 2 days and; * 1800 mg/day (3 tablets twice a day) from the third day and further (but no more than 14 days) until the occurrence of ventilator-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, OR the completion of the patient's participation in the study for other reasons. Tablets are taken 2 times a day 12 hours apart 30 minutes after meal, no more than 14 days.

OTHER

Placebo

Placebo arm patients will receive placebo: * 4 tablets twice a day for the first 2 days and; * 3 tablets twice a day and further (but no more than 14 days) until the occurrence of ventilator-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, OR the completion of the patient's participation in the study for other reasons. Tablets are taken 2 times a day 12 hours apart 30 minutes after meal, no more than 14 days.

Sponsors & Collaborators

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135350 on ClinicalTrials.gov