Status:
NOT_YET_RECRUITING
iNO300 Therapy in Critically Ill Patients With Pneumonia
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Critical Illness
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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) thera...
Detailed Description
This study is designed as a pilot, double-blinded, randomized controlled trial to investigate levels of methemoglobin in the treatment group versus the control group and efficacy of high dose inhaled ...
Eligibility Criteria
Inclusion
- 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
- 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%
- eGFR \< 30 ml/min/1.73m2 or use of continuous renal replacement therapy
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06950294
Start Date
January 1 2026
End Date
December 1 2026
Last Update
December 26 2025
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