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

Phase 2

Not yet recruiting

• Conditions: Gram Negative Pneumonia; Gram-Negative Bacterial Infections; Bacteremia Caused by Gram-Negative Bacteria
• Interventions: Other: Placebo; Drug: Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day

• Registration Number: NCT06135350
• Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

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.

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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.

4. The investigator may also decide to terminate the patient's participation at any time if it is required due to the patient's condition.

5. 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.

6. 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	-
Treatment arm	Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day	-

Primary Outcome Measures

Name	Time	Method
MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV)	Throughout the therapy period (14 days).	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.

Secondary Outcome Measures

Name	Time	Method
Time from the beginning of the MV to the development of urinary tract infection	Throughout the therapy period (14 days).	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.
Proportion of patients who have gram-negative bacteria	Throughout the therapy period (14 days).	The proportion of patients who have gram-negative bacteria isolated from the respiratory tract, with no clinical picture of pneumonia.
Proportion of patients with septic complications	Throughout the therapy period (14 days).	The proportion of patients with septic complications in the study groups during the entire period of therapy.
Proportion of patients who developed urinary tract infection	Throughout the therapy period (14 days).	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 from the beginning of the MV to the development of MV-associated pneumonia	Throughout the therapy period (14 days).	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 from the beginning of the MV to the development of a bloodstream infection	Throughout the therapy period (14 days).	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.
Proportion of patients who developed a bloodstream infection (after the patient was transferred to the MV)	Throughout the therapy period (14 days).	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.
The proportion of fatal outcomes	Throughout the therapy period (14 days).	The proportion of fatal outcomes in the study groups during the entire period of therapy.
Proportion of patients who developed a bloodstream infection (during the entire period of therapy)	Throughout the therapy period (14 days).	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.
Proportion of patients who did not develop MV-associated pneumonia	Throughout the therapy period (14 days).	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).