Trial · NCT06950294
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peaks of methomoglobin | From Day 1 to Day 5 | Continuous recording of MetHb and peaks of MetHb will be determined. |
| Secondary | Nitrogen dioxide level | From Day 1 to Day 5 | Continuous measurement of nitrogen dioxide concentration in the inspiratory limb of breathing circuit |
| Secondary | Feasibility | From enrollment to Day 60 | Referral, recruitment, retention, compliance and follow-up completion rates of the study |
| Secondary | Clinical cure rate of pneumonia | From enrollment to test of cure day (4 -11 days post end of treatment) | 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. |
| Secondary | Clinical improvement rate of pneumonia | Day 5 | 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. |
| Secondary | Microbiologic eradication rate | From enrollment to test of cure day (4 -11 days post end of treatment) | Absence of the baseline pathogen from tracheal aspiration or bronchoalveolar lavage fluid will be confirmed. If it is not possible to obtain an appropriate clinical specimen for culture and the patient has a successful clinical outcome, the response was presumed to be eradication. |
| Secondary | 28-day all cause mortality | From enrollment to Day 28 | All cause mortality from enrollment to Day 28 |
| Secondary | 60-day all cause mortality | From enrollment to Day 60 | All cause mortality from enrollment to Day 60 |
| Secondary | 28-day ventilator free days | From enrollment to Day 28 | Successful liberation from mechanical ventilation should last more than 48 h without re-intubation in patients who have survived 28 days after randomization (extubation was counted from the last successful attempt in patients who have survived 28 days since randomization) and for patients ventilated for 28 days or more or who died before 28 days (irrespective of intubation status), the number of ventilator-free days was recorded at zero. |
| Secondary | Days free from organ support in 28 days | From enrollment to Day 28 | Organ support includes mechanical ventilation, vasopressors and renal replacement therapy. |
| Secondary | Blood stream infection | From enrollment to Day 28 | Positive blood culture with a pathogenic bacterium |
| Secondary | Days free from antibiotics during hospitalization | From enrollment to the day of hospital discharge or death, whichever comes earlier, assessed up to 60 days | Days free from antibiotics during hospitalization |
| Secondary | Acquisition of multidrug-resistant (MDR) infection or colonization | From enrollment to Day 28 | Multidrug-resistant infection is defined as pathogen acquiring non-susceptibility to at least one agent in three or more antibiotic categories |
| Secondary | Hospital stay | From enrollment to the day of hospital discharge or death, whichever comes earlier, assessed up to 60 days | Days from enrollment to the end of hospitalization |
| Secondary | ICU length of stay | From enrollment to the day of ICU discharge or death, whichever comes earlier, assessed up to 60 days | ICU length of stay |
| Secondary | Inflammatory markers | From enrollment to test of cure (4-11 days post end of treatment) | The test includes C reactive protein (CRP), procalcitonin (PCT), monocyte chemoattractant protein-1 (MCP-1), tumor necrosis factor α (TNF α), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 10 (IL-10). |
| Secondary | Relapse rate | From enrollment to Day 28 | Relapse is assessed for patients with hospital-acquired pneumonia at 28-day follow-up after test of cure and defined as recurrence or new appearance of at least two of the three symptoms and signs (fever greater than 38 °C, leukocytosis or leukopenia, and purulent tracheobronchial secretions), along with a new or persistent infiltrate on chest radiography in a patient assessed as clinical cure at TOC. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06950294/registered