Actively Recruiting
iNO300 Therapy in Critically Ill Patients With Pneumonia
Led by Massachusetts General Hospital · Updated on 2026-03-04
34
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled nitric oxide (iNO) therapy at 250 parts per million (ppm), not exceeding 300 ppm. Meanwhile, the benefits of the therapy to treat severely sick patients with pneumonia will be explored. Patients who are 18 years or older, newly diagnosed with pneumonia, and severely sick with requirement of a breathing machine could be included. The main questions it aims to answer are: How does methemoglobin change through the iNO treatment? Does iNO therapy increase the number of patients recovering from pneumonia? Researchers will compare iNO treatment to placebo, which means using the same device as the treatment group without delivering the study drug. Participants will: * Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5 * Be followed up for 60 days
CONDITIONS
Official Title
iNO300 Therapy in Critically Ill Patients With Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Intubated and mechanically ventilated
- Within 72 hours of diagnosis of community- or hospital-acquired pneumonia
- Written informed consent obtained from patients or legally authorized representatives
You will not qualify if you...
- Baseline methemoglobin 3% or higher
- Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease
- Oxygen saturation below 88% on 100% inspired fraction of oxygen
- Anemia with hemoglobin below 7.0 g/dl
- Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20%
- eGFR below 30 ml/min/1.73m2 or use of continuous renal replacement therapy
- Receiving inhaled nitric oxide therapy or decision to start it within 24 hours after randomization
- A decision to do-not-resuscitate (DNR)
- Enrollment in another experimental antimicrobial treatment protocol
- Patients for whom follow-up is expected to be impossible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lorenzo Berra, MD
CONTACT
R
Run Dong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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