iNO300 Therapy in Critically Ill Patients With Pneumonia

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial, called iNO300, is studying the effects of a treatment called inhaled nitric oxide (iNO) in critically ill patients who have pneumonia. The researchers want to find out how this treatment affects a substance in the blood called methemoglobin, and whether it helps patients recover from pneumonia more effectively. To take part in this study, participants need to be adults aged 18 and older who are very sick from pneumonia and are on a breathing machine. They should have been diagnosed with pneumonia within the last 72 hours.

If eligible, participants will receive iNO treatment for 40 minutes every six hours for up to five days. They will be monitored for 60 days to check how they respond to the treatment. It’s important to note that patients will either receive the actual iNO treatment or a placebo, which is a similar device that doesn’t deliver the medication. This helps researchers understand how effective the treatment is. Patients who are pregnant, have certain medical conditions, or are involved in other experimental treatments may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Intubated and mechanically ventilated
• • Within 72h of diagnosis of community- or hospital-acquired pneumonia
• • Written informed consent obtained from patients or legally authorized representatives
• Exclusion Criteria:
• • Obvious signs of pregnancy (the third trimester) or active lactation.
• • Baseline methemoglobin 3% or higher
• • Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease
• • Oxygen saturation \< 88% on 100% inspired fraction of oxygen
• • Anemia with hemoglobin \< 7.0 g/dl
• • Documented history of left ventricular ejection fraction less than 30%
• • Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20%
• • eGFR \< 30 ml/min/1.73m\^2 or use of continuous renal replacement therapy
• • Platelet count less than 30,000/μl and/or high risk of bleeding
• • A decision to do-not-resuscitate
• • Enrollment in another experimental antimicrobial treatment protocol