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iNO300 Therapy in Critically Ill Patients With Pneumonia

ConditionsCritical IllnessPneumonia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High dose inhaled nitric oxide

    Drug

    Inhaled nitric oxide starting at 250-300 ppm, 40min, every 6 hours, from day 1 to day 5. Nitric oxide is delivered using a gas cylinder containing nitric oxide and nitrogen.

  • Sham treatment

    Other intervention

    Sham intervention with the nitric oxide gas cylinder replaced by that containing only nitrogen and all other delivery procedures identical to the intervention group

  • standard therapy

    Other intervention

    Standard therapy pneumonia and critical illness

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: iNO300 groupExperimental treatment 2 interventions
Group B: Control groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Peaks of methomoglobin

Continuous recording of MetHb and peaks of MetHb will be determined.

Time frame
From Day 1 to Day 5

Secondary outcomes

1

Nitrogen dioxide level

Continuous measurement of nitrogen dioxide concentration in the inspiratory limb of breathing circuit

Time frame
From Day 1 to Day 5
2

Feasibility

Referral, recruitment, retention, compliance and follow-up completion rates of the study

Time frame
From enrollment to Day 60
3

Clinical cure rate of pneumonia

Clinical cure is assessed at test of cure (4 -11 days post end of treatment) and defined as resolution of clinical signs and symptoms of pneumonia compared with baseline, including a reduction in SOFA and CPIS scores, improvement or lack of progression in chest imaging, and no requirement for additional antibacterial treatment.

Time frame
From enrollment to test of cure day (4 -11 days post end of treatment)
4

Clinical improvement rate of pneumonia

Clinical improvement is assessed at end of treatment and defined as improvement in 2 or more clinical signs and symptoms of pneumonia compared with baseline, improvement or lack of progression of chest x-ray abnormalities, and no requirement for additional antibacterial treatment. Clinical signs and symptoms of pneumonia include new onset or worsening cough, purulent sputum or increased suction requirements, auscultation findings of pneumonia, dyspnea, tachypnea, or respiratory rate ≥ 30/min, hypoxemia, worsening gas exchange.

Time frame
Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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