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iNO300 Therapy in Critically Ill Patients With Pneumonia

RecruitingEARLY Phase 1Ages 18 Years - anyAllMassachusetts General Hospital
NCT06950294 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 exce

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📋 Eligibility rules (as published)
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: * 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 * Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20% * Receiving inhaled NO therapy or decision to initiate inhaled NO therapy within 24 hours post 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
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What it tests

  • High dose inhaled nitric oxide
  • Sham treatment
  • standard therapy
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Where

1 site
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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