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Clinical Study on the Efficacy of High-Concentration Nitric Oxide (NO) Inhalation Therapy in Patients with Severe Pneumonia Caused by Multidrug-Resistant Bacteria

Clinical Study on the Efficacy of High-Concentration Nitric Oxide (NO) Inhalation Therapy in Patients with Severe Pneumonia Caused by Multidrug-Resistant Bacteria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112185
Enrollment
Unknown
Registered
2025-11-11
Start date
2026-08-31
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe pneumonia

Interventions

Experimental group:Participants in the intervention group will receive inn at 200 ppm two times daily, with each session lasting 30 min, for 5 days, beginning within 24 h of enrollment
Control group:Standard treatment plus sham inhaled nitric oxide (NO)

Sponsors

Jiangdu People's Hospital Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older. 2. Diagnosis of severe pneumonia within 24 h before enrolment. 3. Requirement for invasive mechanical ventilation. 4. Suspected or conffrmed infection caused by multidrug-resistant (MDR) bacteria; confirmation may be based on sputum or bronchoalveolar lavage fluid (BALF) culture. 5. Written informed consent provided by the patient or a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Currently participating in another clinical trial; 2. Active pulmonary malignancy, or a history of lung transplantation or lung resection; 3. Severe burns involving more than 40% of the total body surface area; 4. Severe hepatic or renal dysfunction, defined as Child–Pugh class C liver disease or an estimated glomerular filtration rate (eGFR) <30 mL/min; 5. Currently receiving renal replacement therapy; 6. Previous treatment with inhaled nitric oxide (NO) before enrollment; 7. Presence of methemoglobinemia; 8. Major bleeding at the time of screening.

Design outcomes

Primary

MeasureTime frame
change in CPIS from baseline to day 7;

Secondary

MeasureTime frame
Mortality Rate;ventilator-free days through day 28;vasopressor-free days through day 28;antibiotic-free days through day 28;ICU -free days through day 28;hospital-free days through day 28.;CPIS scores;SOFA scores;microbiological eradication rate;citrullinated histone H3;cell-free DNA;Pao2/FiO2;Methemoglobin;NO2;Creatinine;Airway hyperresponsiveness events;Incidence of acute kidney injury (AKI);

Countries

China

Contacts

Public ContactPenglei Yang

Jiangdu People's Hospital Affiliated to Yangzhou University

yangpengleichina@outlook.com+86 199 6260 2507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026