Community-acquired Pneumonia Clinical Trial
Official title:
The Effectiveness of Adding Multiple Intermittent High-dose Inhalations of Nitric Oxide to Standard Antibacterial Therapy in the Treatment of Pneumonia
This is a multicenter, prospective randomized controlled trial. At least 2 but no more than 5 centers are expected to participate in the study. The primary objective is to test the hypothesis that the addition of high-dose inhaled nitric oxide therapy to standard treatment has a positive effect on the clinical course of pneumonia and the structure and function of cardiopulmonary system. Number of participants: 200, including the subproject NO-PNEUMONIA-CAP - 100 CAP participants, the subproject NO-PNEUMONIA-NP - 100 NP participants. Number of groups: 4 Inhalation of iNO at a dose of 200 ppm for 30 minutes under the control of methemoglobin level (no more than 5%) three times a day if the patient is allocated to the main group. The general course of iNO therapy will last until the pneumonia resolves, but no more than 7 days. Recording of vital signs and safety assessment will be carried out immediately before the initiation of NO therapy and every 15 minutes after its start (pulse, blood pressure, respiratory rate, SpO2, temperature, MetHb level).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 15, 2027 |
Est. primary completion date | January 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP). 2. Spontaneous breathing. 3. Age > 18 years. 4. Signed informed consent. 5. Negative result of immunochromatographic Severe acute respiratory syndrome-related coronavirus 2 rapid antigen test on the day of diagnosis of pneumonia. Diagnostic criteria for NP The diagnosis of NP is considered established when the number of points on the Clinical Pulmonary Infection Score (CPIS) is greater than 6: Diagnostic criteria for CAP: Radiologically confirmed focal pulmonary opacity and at least 2 clinical symptoms and signs of the following: 1. acute fever at the onset of the disease (t° > 38.0°C); 2. cough with sputum; 3. physical signs (crepitus/fine rales, bronchial breathing, shortening of percussion sound); 4. leukocytosis > 10x109/l and/or left shift (> 10%) Exclusion Criteria: 1. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, infective endocarditis etc.). 2. Mechanical ventilation 3. Presence of tracheostomy 4. Patient's participation in another clinical trial at the time of screening or within the previous 3 months. 5. Concomitant pulmonary disease with the need for respiratory support before the development of pneumonia. 6. History of malignancy or other irreversible diseases/conditions with a life expectancy of less than 1 year. 7. Presence of HIV infection |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Cardiology Research Institute Tomsk National Research Medical Center | Tomsk | Select... |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pneumonia resolution time (days) | Pneumonia resolution time is assessed as number of days from the date of randomization till pneumonia resolution. | 30 days from the date of randomization | |
Secondary | Fever higher than 37°C (days) | Fever is assessed in number of days when the level of fever is higher than 37°C | 30 days from the date of randomization | |
Secondary | Total leukocyte counts (10*9/L) | The difference in the levels of leukocytes (counts) is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins in the study groups | 72 hours from the start of therapy | |
Secondary | Immature cell counts (percentage) | The difference between the levels of immature cells (counts) in the leukocyte formula is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins in the study groups | 72 hours from the start of therapy | |
Secondary | Pneumonia resolution-associated change in total leukocyte counts (10*9/L) | The difference in the levels of leukocytes (counts) is assessed between the time points corresponding to the start of therapy and the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, the change is assessed between the date of randomization and day 30. | 30 days from the date of randomization | |
Secondary | Pneumonia resolution-associated change in immature cell counts (percentage) | The difference in the levels of leukocytes (counts) is assessed between the time points corresponding to the start of therapy and the day of pneumonia resolution. In case pneumonia does not resolves within 30 days, the change is assessed between the date of randomization and day 30. | 30 days from the date of randomization | |
Secondary | C-reactive protein (CRP) level | The difference in the levels of C-reactive protein (mg/L) is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins. | 72 hours from the start of therapy | |
Secondary | Pneumonia resolution-associated change in C-reactive protein level (mg/L) | The difference in the levels of C-reactive protein (mg/L) is assessed between the time points corresponding to the start of therapy and the day of pneumonia resolution. In case pneumonia does not resolves within 30 days, the change is assessed between the date of randomization and day 30. | 30 days from the date of randomization | |
Secondary | Procalcitonin (PCT) level (ng/mL) | The difference in the levels of procalcitonin (PCT) (ng/mL) is assessed between the time points corresponding to the start of therapy and 72 hours after therapy begins. | 72 hours from the start of therapy | |
Secondary | Pneumonia resolution-associated change in procalcitonin (PCT) level (ng/mL) | The difference in the levels of procalcitonin (PCT) (ng/mL) is assessed between the time points corresponding to the start of therapy and the day of pneumonia resolution. In case pneumonia does not resolves within 30 days, the change is assessed between the date of randomization and day 30. | 30 days from the date of randomization | |
Secondary | Respiratory support time (days) | Respiratory support time is assessed as number of days when respiratory support is required. | 30 days from the date of randomization | |
Secondary | Frequency of changing antibacterial treatment regimens (times) | Frequency of changing antibacterial treatment regimens is assessed as number of modifications to antibacterial treatment required due to its ineffectiveness. | 30 days from the date of randomization | |
Secondary | Incidence of sepsis (percentage) | Incidence of sepsis is assessed as percentage of cases. | 30 days from the date of randomization | |
Secondary | Incidence of septic shock (percentage) | Incidence of septic shock is assessed as percentage of cases. | 30 days from the date of randomization | |
Secondary | Incidence of oxygen saturation decrease (percentage) | Incidence of oxygen saturation decrease is assessed as percentage of cases where patients with initially normal oxygen saturation level have oxygen saturation below 95% and/or patients with initially reduced oxygen saturation level have a drop in oxygen saturation by 3% and more after 72 hours the start of therapy. | 30 days from the date of randomization | |
Secondary | Incidence of adverse computer tomography (CT) findings (percentage) | Incidence of adverse computer tomography (CT) findings is assessed as percentage of cases with adverse findings on CT on day 3 after the start of therapy.hours of therapy in the study groups | 72 hours from the start of therapy | |
Secondary | Right atrial volume index (RAVI) (mL/m2) | Right atrial volume index (RAVI) (mL/m2) is measured by echocardiography at day 3 after the start of therapy | 72 hours from the start of therapy | |
Secondary | Right ventricular volume index (mL/m2) | Right ventricular volume index (RAVI) (mL/m2) is measured by echocardiography at day 3 after the start of therapy. | 72 hours from the start of therapy | |
Secondary | Pneumonia resolution-associated right atrial volume index (RAVI) (mL/m2) | Right atrial volume index (RAVI) (mL/m2) is measured by echocardiography on the day of pneumonia resolution. | 30 days from the date of randomization | |
Secondary | Pneumonia resolution-associated right ventricular volume index (mL/m2) | Right ventricular volume index (mL/m2) is measured by echocardiography on the day of pneumonia resolution. | 30 days from the date of randomization | |
Secondary | Increased peak tricuspid regurgitation velocity (percentage) | Incidence of increase in peak tricuspid regurgitation velocity is assessed as percentage of cases on day 3 after the start of therapy. | 72 hours from the start of therapy | |
Secondary | Increased peak tricuspid regurgitation velocity (percentage) | Incidence of increase in peak tricuspid regurgitation velocity is assessed as percentage of cases on day 30 after the start of therapy. | 30 days from the date of randomization | |
Secondary | Six-minute walk test (6MWT) distance (meters) | Six-minute walk test (6MWT) distance (meters) is assessed at the day of pneumonia resolution. In case pneumonia does not resolves within 30 days, the 6MWT distance is assessed on day 30. | 30 days from the date of randomization | |
Secondary | Lung vital capacity (L) | Lung vital capacity is assessed in liters (L) at the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, lung vital capacity is assessed at day 30. | 30 days from the date of randomization | |
Secondary | Forced vital capacity (L) | Forced vital capacity is assessed in liters (L) at the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, forced vital capacity is assessed on day 30. | 30 days from the date of randomization | |
Secondary | Forced expiratory volume (L/s) | Forced expiratory volume is assessed in liters per second (L/s) at the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, forced expiratory volume is assessed on day 30. | 30 days from the date of randomization | |
Secondary | Peak expiratory flow (L/s) | Peak expiratory flow is assessed in liters per second (L/s) at the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, peak expiratory flow is assessed on day 30. | 30 days from the date of randomization | |
Secondary | Quality of life (score) | Quality of life is assessed according to EQ-5D-5L quality of life questionnaire score on day 3 after the start of therapy. | 72 hours from the date of randomization | |
Secondary | Quality of life (score) | Quality of life is assessed according to EQ-5D-5L quality of life questionnaire score at the day of pneumonia resolution. In case pneumonia does not resolve within 30 days, quality of life is assessed on day 30 | 30 days from the date of randomization | |
Secondary | Mortality caused by pneumonia or its complications (percentage) | Mortality due to pneumonia or its complications is assessed as percentage | 30 days from the date of randomization |
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