Gram Negative PneumoniaPhase 2NCT06135350
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
A Phase 2 study testing Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day in people with Gram Negative Pneumonia and Gram-Negative Bacterial Infections, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram Negative Pneumonia, Gram-Negative Bacterial Infections, Bacteremia Caused by Gram-Negative Bacteria
- What is being tested?
- Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 2 sitesRussia
- Study dates
- 6 Nov 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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%;
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- 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.
Who cannot join
- 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 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:
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
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
Anastasia A. Anderzhanova, +79161937499, Gkb1.clinpharm@gmail.com
- Recruiting
City Clinical Hospital No. 24 of the Moscow City Department of Health
Moscow, Moscow, 127015
Sergey K. Zyryanov, +7 499 251-00-59, zelena0566@mail.ru
About this study
Official title: 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 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:
Read more
- 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
- Being tested
- Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day, Placebo
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/dayDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day |
| Placebo arm | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the therapy period (14 days).
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the therapy period (14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start6 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135350
- Sponsor's protocol ID
- 06-FT-2021, v. 3.0, 03.11.2022
- Status last verified
- May 2025
- First submitted
- 9 Nov 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06135350
- Acronym / sponsor ID
- 06-FT-2021, v. 3.0, 03.11.2022
- Conditions
- Gram Negative Pneumonia, Gram-Negative Bacterial Infections, Bacteremia Caused by Gram-Negative Bacteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day |
| Placebo arm | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 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:
Key exclusion criteria (9 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/dayTreatment 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. | Drug | Treatment arm |
| PlaceboPlacebo 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. | Other | Placebo arm |
Primary outcome
MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV)
Time frame: 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.
10 secondary outcomes
Time from the beginning of the MV to the development of MV-associated pneumonia
Time frame: Throughout the therapy period (14 days).
Time from the beginning of the MV to the development of a bloodstream infection
Time frame: Throughout the therapy period (14 days).
Time from the beginning of the MV to the development of urinary tract infection
Time frame: Throughout the therapy period (14 days).
Proportion of patients who developed urinary tract infection
Time frame: Throughout the therapy period (14 days).
Proportion of patients who did not develop MV-associated pneumonia
Time frame: Throughout the therapy period (14 days).
Proportion of patients who have gram-negative bacteria
Time frame: Throughout the therapy period (14 days).
Proportion of patients who developed a bloodstream infection (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)
Time frame: Throughout the therapy period (14 days).
Proportion of patients with septic complications
Time frame: Throughout the therapy period (14 days).
The proportion of fatal outcomes
Time frame: Throughout the therapy period (14 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day in people with Gram Negative Pneumonia and Gram-Negative Bacterial Infections, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nailya A. Zigangirova, Doctor of Biological Sciences (+7 (499) 193-30-01, zigangirova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MV-associated pneumonia caused by gram-negative bacteria (72-120 hours from the moment of tracheal intubation and the start of the MV) (time frame: Throughout the therapy period (14 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.