High-dose inhaled nitric oxide for treating pneumonia

The Effectiveness of Adding Multiple Intermittent High-dose Inhalations of Nitric Oxide to Standard Antibacterial Therapy in the Treatment of Pneumonia

This study is testing if high-dose inhaled nitric oxide can help people with pneumonia feel better when used alongside standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Locations: 1 site (Tomsk, Select...)
• Trial ID: NCT06170372 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective randomized controlled trial aims to evaluate the effectiveness of high-dose inhaled nitric oxide therapy in conjunction with standard treatment for pneumonia. The study will involve 200 participants, divided into two groups for community-acquired pneumonia and nosocomial pneumonia, receiving inhalations of nitric oxide at a controlled dose. The primary objective is to assess the impact of this therapy on the clinical course of pneumonia and the cardiopulmonary system's function. Safety assessments and vital sign monitoring will be conducted throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of either nosocomial pneumonia or community-acquired pneumonia.

Not a fit: Patients who are not spontaneously breathing or have contraindications to nitric oxide therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with pneumonia.

How similar studies have performed: While the use of inhaled nitric oxide has been explored in various contexts, this specific application for pneumonia treatment is relatively novel.

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

Where this trial is running

Tomsk, Select...

• Cardiology Research Institute Tomsk National Research Medical Center — Tomsk, Select..., Russia (Recruiting)

Study contacts

• Principal investigator: Tatiana P Kalashnikova, MD, PhD — Cardiology Research Institute, Tomsk National Research Medical Center
• Study coordinator: Tatiana P. Kalashnikova, MD, PhD

Conditions Nosocomial Pneumonia; Community-acquired Pneumonia