Evaluating Fluorothiazinone for Preventing Bacterial Infections in Ventilated Patients

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

This study is testing if a new drug called Fluorothiazinone can help prevent bacterial infections in patients on ventilators in the ICU.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation (Academic / other)
• Locations: 2 sites (Moscow, Moscow and 1 other locations)
• Trial ID: NCT06135350 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of Fluorothiazinone in preventing nosocomial gram-negative bacterial infections in patients on mechanical ventilation. Participants will receive either Fluorothiazinone or a placebo alongside standard infection prevention measures. The study will evaluate clinical outcomes, antibacterial efficacy, safety, and pharmacokinetics of the drug. The trial is designed for patients in intensive care units with confirmed SARS-CoV-2 and severe pneumonia or other acute conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are in the ICU with confirmed SARS-CoV-2 and severe pneumonia or other acute conditions.

Not a fit: Patients who are not on mechanical ventilation or do not have confirmed bacterial infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of bacterial infections in critically ill patients on mechanical ventilation.

How similar studies have performed: While similar approaches have been explored, the specific use of Fluorothiazinone in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Patients are at least 18 years old, male and female.
3. Patients who are in the ICU (intensive care unit).
4. 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:
   * 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.
5. Patients who have been on ALV (artificial lung ventilation) for no more than 12 hours.
6. 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.
7. 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.

Exclusion Criteria:

1. The patient was not switched to ALV within 72 hours (3 days) after receiving the investigational drug.
2. People who have a bloodstream infection, identified during the screening.
3. A patient may terminate his/her participation in the study at any time for any reason and without any explanation.

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:

* 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).

Where this trial is running

Moscow, Moscow and 1 other locations

• 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 (Recruiting)
• City Clinical Hospital No. 24 of the Moscow City Department of Health — Moscow, Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Nailya A. Zigangirova, Doctor of Biological Sciences

Conditions Gram Negative Pneumonia; Gram-Negative Bacterial Infections; Bacteremia Caused by Gram-Negative Bacteria