Status:
RECRUITING
High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Nosocomial Pneumonia
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a multicenter, prospective randomized controlled trial. At least 2 but no more than 5 centers are expected to participate in the study. The primary objective is to test the hypothesis that th...
Detailed Description
Principal investigator: T.P. Kalashnikova, MD, PhD. Sub-investigators: N.O.Kamenshchikov, MD, PhD, I.V. Kravchenko, MD, Yu.A. Arsenyeva, MD, Yu.K. Podoksenov, MD, PhD, DMedSci, M.S. Kozulin, MD, M.B. ...
Eligibility Criteria
Inclusion
- An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP).
- Spontaneous breathing.
- Age \> 18 years.
- Signed informed consent.
- Negative result of immunochromatographic Severe acute respiratory syndrome-related coronavirus 2 rapid antigen test on the day of diagnosis of pneumonia.
- Diagnostic criteria for NP The diagnosis of NP is considered established when the number of points on the
- Clinical Pulmonary Infection Score (CPIS) is greater than 6:
- Diagnostic criteria for CAP:
- Radiologically confirmed focal pulmonary opacity and at least 2 clinical symptoms and signs of the following:
- acute fever at the onset of the disease (t° \> 38.0°C);
- cough with sputum;
- physical signs (crepitus/fine rales, bronchial breathing, shortening of percussion sound);
- leukocytosis \> 10x109/l and/or left shift (\> 10%)
Exclusion
- Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, infective endocarditis etc.).
- Mechanical ventilation
- Presence of tracheostomy
- Patient's participation in another clinical trial at the time of screening or within the previous 3 months.
- Concomitant pulmonary disease with the need for respiratory support before the development of pneumonia.
- History of malignancy or other irreversible diseases/conditions with a life expectancy of less than 1 year.
- Presence of HIV infection
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06170372
Start Date
January 15 2024
End Date
January 15 2027
Last Update
April 10 2025
Active Locations (1)
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1
Cardiology Research Institute Tomsk National Research Medical Center
Tomsk, Select..., Russia, 634012