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Tests treatment safety and results for Gram Negative Pneumonia
Official title 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
ClinicalTrials.gov ID: NCT06135350
What this study is testing
What is Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day?
Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gram negative pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients are at least 18 years old, male and female.
- Patients who are in the ICU (intensive care unit).
- Patients with: 4.1. Laboratory confirmed SARS-CoV-2 (Severe acute respiratory syndrome-related coronavirus-2) on screening (a patient's coronavirus...
- SpO2 (peripheral oxygen saturation) ≤ 93%;
You likely can't join 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. 3\. The investigator may also...
- 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...
See the full eligibility criteria
- 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: 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...
- 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...
- 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...
- 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. 3\. The investigator may also decide to terminate the patient's participation at any time if it is...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Moscow, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.