NCT06170372 High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia
| NCT ID | NCT06170372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Condition | Nosocomial Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-01-15 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 the addition of high-dose inhaled nitric oxide therapy to standard treatment has a positive effect on the clinical course of pneumonia and the structure and function of cardiopulmonary system. Number of participants: 200, including the subproject NO-PNEUMONIA-CAP - 100 CAP participants, the subproject NO-PNEUMONIA-NP - 100 NP participants. Number of groups: 4 Inhalation of iNO at a dose of 200 ppm for 30 minutes under the control of methemoglobin level (no more than 5%) three times a day if the patient is allocated to the main group. The general course of iNO therapy will last until the pneumonia resolves, but no more than 7 days. Recording of vital signs and safety assessment will be carried out immediately before the initiation of NO therapy and every 15 minutes after its start (pulse, blood pressure, respiratory rate, SpO2, temperature, MetHb level).
Eligibility Criteria
Inclusion Criteria: 1. An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP). 2. Spontaneous breathing. 3. Age \> 18 years. 4. Signed informed consent. 5. 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: 1. acute fever at the onset of the disease (t° \> 38.0°C); 2. cough with sputum; 3. physical signs (crepitus/fine rales, bronchial breathing, shortening of percussion sound); 4. leukocytosis \> 10x109/l and/or left shift (\> 10%) Exclusion Criteria: 1. 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.). 2. Mechanical ventilation 3. Presence of tracheostomy 4. Patient's participation in another clinical trial at the time of screening or within the previous 3 months. 5. Concomitant pulmonary disease with the need for respiratory support before the development of pneumonia. 6. History of malignancy or other irreversible diseases/conditions with a life expectancy of less than 1 year. 7. Presence of HIV infection
Contact & Investigator
Tatiana P Kalashnikova, MD, PhD
PRINCIPAL INVESTIGATOR
Cardiology Research Institute, Tomsk National Research Medical Center
Frequently Asked Questions
Who can join the NCT06170372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nosocomial Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06170372 currently recruiting?
Yes, NCT06170372 is actively recruiting participants. Contact the research team at kalashnikova-t@mail.ru for enrollment information.
Where is the NCT06170372 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT06170372 clinical trial?
NCT06170372 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. The principal investigator is Tatiana P Kalashnikova, MD, PhD at Cardiology Research Institute, Tomsk National Research Medical Center. The trial plans to enroll 200 participants.