A Phase 2 interventional study of Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day and Placebo in Gram Negative Pneumonia, Gram-Negative Bacterial Infections and Bacteremia Caused by Gram-Negative Bacteria, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation. Recruiting at 2 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Phase 2, Interventional, and Prevention
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:
Researchers will compare results for the treatment and the placebo arms.
58 studies on the registry are indexed under Gram-Negative Bacterial Infections; 10 are open to participants now.
This study's planned enrollment of 234 is above the median of 70 across 43 interventional studies indexed under Gram-Negative Bacterial Infections.
Browse Gram-Negative Bacterial Infections studies →Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with:
4.1. 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:
Exclusion Criteria:
3. The investigator may also decide to terminate the patient's participation at any time if it is required due to the patient's condition.
4. The sponsor or the regulator may also request the trial to be terminated early, either due to how the trial was conducted, or due to application safety data, or other reasons.
5. The main reasons why the patient may withdraw from the study are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day
Other: Placebo
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.
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.
MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV)
The proportion of patients in the study groups without clinically and microbiologically confirmed MV-associated pneumonia caused by gram-negative bacteria, which developed no earlier than 72 hours (3 days) and no later than 120 hours (5 days) from the moment of tracheal intubation and the start of the MV, in the absence of signs of pulmonary infection at the time of intubation.
Time frame: Throughout the therapy period (14 days).
Time from the beginning of the MV to the development of MV-associated pneumonia
The time from the beginning of the MV to the development of MV-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
Time from the beginning of the MV to the development of a bloodstream infection
The time from the beginning of the MV to the development of a bloodstream infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
Time from the beginning of the MV to the development of urinary tract infection
The time from the beginning of the MV to the development of urinary tract infection caused by gram-negative bacteria, confirmed microbiologically in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
Proportion of patients who developed urinary tract infection
The proportion of patients who developed urinary tract infection caused by gram-negative bacteria, confirmed microbiologically, in the study groups during the entire period of reception of the investigative drug (IMP).
Time frame: Throughout the therapy period (14 days).
Proportion of patients who did not develop MV-associated pneumonia
The proportion of patients who did not develop MV-associated pneumonia caused by gram-negative bacteria, confirmed clinically and microbiologically, in the study groups during the entire period of reception of the investigative drug (IMP).
Time frame: Throughout the therapy period (14 days).
Proportion of patients who have gram-negative bacteria
The proportion of patients who have gram-negative bacteria isolated from the respiratory tract, with no clinical picture of pneumonia.
Time frame: Throughout the therapy period (14 days).
Proportion of patients who developed a bloodstream infection (during the entire period of therapy)
The proportion of patients who developed a bloodstream infection caused by gram-negative microflora, confirmed microbiologically in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
Proportion of patients who developed a bloodstream infection (after the patient was transferred to the MV)
The proportion of patients who developed a bloodstream infection caused by gram-negative microflora, confirmed microbiologically in the study groups after the patient was transferred to the MV.
Time frame: Throughout the therapy period (14 days).
Proportion of patients with septic complications
The proportion of patients with septic complications in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
The proportion of fatal outcomes
The proportion of fatal outcomes in the study groups during the entire period of therapy.
Time frame: Throughout the therapy period (14 days).
Comparative characteristics of colonization of the respiratory and urinary tracts
Comparative characteristics of colonization of the respiratory and urinary tracts by individual pathogens in patients on the MV.
Time frame: Throughout the therapy period (14 days).
Comparative assessment of the condition on the SOFA scale
Comparative assessment of the condition on the Sequential Organ Failure Assessment (SOFA) scale. Comparative assessment of the condition on the SOFA scale throughout the study. Score ranges from 0 (best) to 24 (worst) points.
Time frame: Throughout the therapy period (14 days).
Comparative assessment of the condition on the APACHE II scale
Comparative assessment of the condition on the Acute Physiology and Chronic Health Evaluation II (APACHE II) scale throughout the study. Calculates an integer score from 0 to 71 based on multiple measurements. Higher scores correspond to more severe disease and a higher risk of death.
Time frame: Throughout the therapy period (14 days).
Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.
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Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation