High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia

NCT06170372 | Recruiting

• 1 other identifier: NO PNEUMONIA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Nosocomial Pneumonia; Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Pneumonia resolution time (days)

  Pneumonia resolution time is assessed as number of days from the date of randomization till pneumonia resolution.

  30 days from the date of randomization

Secondary Outcomes (29)

• Fever higher than 37˚C (days)

  30 days from the date of randomization

• Total leukocyte counts (10*9/L)

  72 hours from the start of therapy

• Immature cell counts (percentage)

  72 hours from the start of therapy

• Pneumonia resolution-associated change in total leukocyte counts (10*9/L)

  30 days from the date of randomization

• Pneumonia resolution-associated change in immature cell counts (percentage)

  30 days from the date of randomization

Study Arms (4)

Main group with nosocomial pneumonia

EXPERIMENTAL

Standard antibacterial therapy + Nitric Oxide 200 ppm 3 times a day for 30 minutes under the control of methemoglobin level (no more than 5%). The general course of Nitric Oxide therapy will last until the pneumonia resolves, but no more than 7 days.

Drug: 200 ppm Nitric Oxide

Control group with nosocomial pneumonia

ACTIVE COMPARATOR

Standard antibacterial therapy + medical air without Nitric Oxide 3 times a day for 30 minutes until the pneumonia resolves, but no more than 7 days.

Drug: Sham treatment

Main group with community acquired pneumonia

EXPERIMENTAL

Standard antibacterial therapy + Nitric Oxide 200 ppm 3 times a day for 30 minutes under the control of methemoglobin level (no more than 5%). The general course of Nitric Oxide therapy will last until the pneumonia resolves, but no more than 7 days.

Drug: 200 ppm Nitric Oxide

Control group with community acquired pneumonia

ACTIVE COMPARATOR

Standard antibacterial therapy + medical air without Nitric Oxide 3 times a day for 30 minutes until the pneumonia resolves, but no more than 7 days.

Drug: Sham treatment

Interventions

200 ppm Nitric Oxide DRUG

NO will be supplemented at 200-ppm concentration 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days

Also known as: nitrogen monoxide

Main group with community acquired pneumonia; Main group with nosocomial pneumonia

Sham treatment DRUG

Oxygen-air mixture without NO 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days

Also known as: Oxygen-Air Mixture

Control group with community acquired pneumonia; Control group with nosocomial pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute Tomsk National Research Medical Center

Tomsk, Select..., 634012, Russia

RECRUITING

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Community-Acquired Pneumonia

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Tatiana P Kalashnikova, MD, PhD

  Cardiology Research Institute, Tomsk National Research Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana P. Kalashnikova, MD, PhD

CONTACT

+7 9138141664; kalashnikova-t@mail.ru

Nikolay O. Kamenshchikov, MD, PhD

CONTACT

+79138183657; nikolajkamenof@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, senior researcher of Laboratory

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: January 15, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

RU (1)