RecruitingNot ApplicableNCT06170372

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

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


Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Enrollment

200 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 200 ppm Nitric Oxide and a drug called Sham treatment for people with community-acquired pneumonia and nosocomial pneumonia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG200 ppm Nitric Oxide

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

DRUGSham treatment

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


Locations(1)

Cardiology Research Institute Tomsk National Research Medical Center

Tomsk, Select..., Russia

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NCT06170372


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