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 | Recruiting Phase 2

• 1 other identifier: 06-FT-2021, v. 3.0, 03.11.2022
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout the therapy period (14 days).

Secondary Outcomes (10)

• Time from the beginning of the MV to the development of MV-associated pneumonia

  Throughout the therapy period (14 days).

• Time from the beginning of the MV to the development of a bloodstream infection

  Throughout the therapy period (14 days).

• Time from the beginning of the MV to the development of urinary tract infection

  Throughout the therapy period (14 days).

• Proportion of patients who developed urinary tract infection

  Throughout the therapy period (14 days).

• Proportion of patients who did not develop MV-associated pneumonia

  Throughout the therapy period (14 days).

Other Outcomes (3)

• Comparative characteristics of colonization of the respiratory and urinary tracts

  Throughout the therapy period (14 days).

• Comparative assessment of the condition on the SOFA scale

  Throughout the therapy period (14 days).

• Comparative assessment of the condition on the APACHE II scale

  Throughout the therapy period (14 days).

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Placebo arm

PLACEBO COMPARATOR

Other: Placebo

Interventions

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

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.

Treatment arm

Placebo OTHER

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.

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• The patient was not switched to ALV within 72 hours (3 days) after receiving the investigational drug.
• People who have a bloodstream infection, identified during the screening.
• A patient may terminate his/her participation in the study at any time for any reason and without any explanation.
• \. The investigator may also decide to terminate the patient's participation at any time if it is required due to the patient's condition.
• \. 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.
• \. The main reasons why the patient may withdraw from the study are:
• Refusal of the patient to participate in the study;
• Development of an AE (adverse event) / SAE (serious adverse event) that prevents further study participation;
• The occurrence of concomitant somatic diseases / symptoms or exacerbation of chronic diseases not related to the investigational drug (at the discretion of the medical investigator).

Sponsors & Collaborators

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

Study Sites (2)

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, 119049, Russia

RECRUITING

City Clinical Hospital No. 24 of the Moscow City Department of Health

Moscow, Moscow, 127015, Russia

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

Tablets

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Nailya A. Zigangirova, Doctor of Biological Sciences

CONTACT

+7 (499) 193-30-01; zigangirova@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: November 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)