[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529176":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":40,"centralContacts":45,"locations":56,"responsibleParty":71,"collaborators":50,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":50,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":50,"enrollmentInfo":83,"targetDuration":50,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":50,"overallStatus":59,"whyStopped":50,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",[8,14,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Main group with nosocomial pneumonia","EXPERIMENTAL","Standard antibacterial therapy + Nitric Oxide 200 ppm 3 times a day for 30 minutes under the control of methemoglobin level (no more than 5%). The general course of Nitric Oxide therapy will last until the pneumonia resolves, but no more than 7 days.",[13],"Drug: 200 ppm Nitric Oxide",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group with nosocomial pneumonia","ACTIVE_COMPARATOR","Standard antibacterial therapy + medical air without Nitric Oxide 3 times a day for 30 minutes until the pneumonia resolves, but no more than 7 days.",[19],"Drug: Sham treatment",{"label":21,"type":10,"description":11,"interventionNames":22},"Main group with community acquired pneumonia",[13],{"label":24,"type":16,"description":17,"interventionNames":25},"Control group with community acquired pneumonia",[19],[27,34],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","200 ppm Nitric Oxide","NO will be supplemented at 200-ppm concentration 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days",[21,9],[33],"nitrogen monoxide",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Sham treatment","Oxygen-air mixture without NO 3 times a day for 30 min until the pneumonia resolves, but no more than 7 days",[24,15],[39],"Oxygen-Air Mixture",[41],{"name":42,"affiliation":43,"role":44},"Tatiana P Kalashnikova, MD, PhD","Cardiology Research Institute, Tomsk National Research Medical Center","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Tatiana P. Kalashnikova, MD, PhD","CONTACT","+7 9138141664",null,"kalashnikova-t@mail.ru",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Nikolay O. Kamenshchikov, MD, PhD","+79138183657","nikolajkamenof@mail.ru",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":50},"Cardiology Research Institute Tomsk National Research Medical Center","RECRUITING","Tomsk","Select...","634012","Russia","RU",{"type":66,"coordinates":67},"Point",[68,69],84.98216,56.50049,{"lat":69,"lon":68},{"type":44,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Tatiana P. Kalashnikova","MD, PhD, senior researcher of Laboratory","100529176","high-dose-inhalations-of-nitric-oxide-in-the-treatment-of-pneumonia-100529176",false,"NCT06170372","High-dose Inhalations of Nitric Oxide in the Treatment of Pneumonia","The Effectiveness of Adding Multiple Intermittent High-dose Inhalations of Nitric Oxide to Standard Antibacterial Therapy in the Treatment of Pneumonia","Inclusion Criteria:\n\n1. An established diagnosis of Nosocomial Pneumonia (NP) after cardiac surgery under cardiopulmonary bypass (CPB) or hospitalization for Community-acquired pneumonia (CAP).\n2. Spontaneous breathing.\n3. Age \\> 18 years.\n4. Signed informed consent.\n5. Negative result of immunochromatographic Severe acute respiratory syndrome-related coronavirus 2 rapid antigen test on the day of diagnosis of pneumonia.\n\nDiagnostic criteria for NP The diagnosis of NP is considered established when the number of points on the\n\nClinical Pulmonary Infection Score (CPIS) is greater than 6:\n\nDiagnostic criteria for CAP:\n\nRadiologically confirmed focal pulmonary opacity and at least 2 clinical symptoms and signs of the following:\n\n1. acute fever at the onset of the disease (t° \\> 38.0°C);\n2. cough with sputum;\n3. physical signs (crepitus\u002Ffine rales, bronchial breathing, shortening of percussion sound);\n4. leukocytosis \\> 10x109\u002Fl and\u002For left shift (\\> 10%)\n\nExclusion Criteria:\n\n1. 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.).\n2. Mechanical ventilation\n3. Presence of tracheostomy\n4. Patient's participation in another clinical trial at the time of screening or within the previous 3 months.\n5. Concomitant pulmonary disease with the need for respiratory support before the development of pneumonia.\n6. History of malignancy or other irreversible diseases\u002Fconditions with a life expectancy of less than 1 year.\n7. Presence of HIV infection","ALL","18 Years",{"count":84,"type":85},200,"ESTIMATED","INTERVENTIONAL",[88],"NA","This is a multicenter, prospective randomized controlled trial. At least 2 but no more than 5 centers are expected to participate in the study.\n\nThe 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.\n\nNumber of participants: 200, including the subproject NO-PNEUMONIA-CAP - 100 CAP participants, the subproject NO-PNEUMONIA-NP - 100 NP participants.\n\nNumber 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).",[91,92],"Nosocomial Pneumonia","Community-acquired Pneumonia","2025-04-07",{"date":95,"type":96},"2025-04-10","ACTUAL",{"date":98,"type":96},"2024-01-15",{"date":100,"type":85},"2027-01-15",{"name":5,"class":6},1]