[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519582":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":69,"collaborators":44,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":44,"enrollmentInfo":82,"targetDuration":44,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrogen Peroxide","EXPERIMENTAL","Intervention group: daily oral care will be provided according to the local standard, with 3% hydrogen peroxide, oral assessment and teeth brushing will be completed twice daily (morning and evening).",[13],"Drug: Oroxid®",{"label":15,"type":16,"description":17,"interventionNames":18},"Chlorhexidine","ACTIVE_COMPARATOR","Control group: daily oral care will be provided according to the local standard, with 0,2% chlorhexidine, oral assessment and teeth brushing will be completed twice daily (morning and evening).",[19],"Drug: Chlorhexidine mouthwash",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oroxid®","All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local \"ventilator bundle \"; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using Oroxid® mouthwash.",[9],[27],"3% hydrogen peroxide mouthwash",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Chlorhexidine mouthwash","All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local \"ventilator bundle \"; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using 0,2% chlorhexidine",[15],[33],"0,2% chlorhexidine gluconate",[35],{"name":36,"affiliation":37,"role":38},"Kateřina Jiroutková, MD","3rd Faculty of Medicine, Charles University and FNKV, Prague","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Kateřina Rambousková, MD","CONTACT","+420 721 185 134",null,"kacakoubkova@seznam.cz",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Adela Jiroudkova","+420 602 145 168","adela.jiroudkova@ruk.cuni.cz",[51],{"facility":52,"status":53,"city":54,"state":44,"zip":55,"country":56,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"3rd Faculty of Medicine and FNKV","RECRUITING","Prague","11000","Czechia",{"type":58,"coordinates":59},"Point",[60,61],14.42076,50.08804,{"lat":61,"lon":60},[64,66],{"name":65,"role":42,"phone":43,"phoneExt":44,"email":45},"Kateřina Rambousková",{"name":36,"role":42,"phone":67,"phoneExt":44,"email":68},"724259492","katka.nova@post.cz",{"type":38,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Kateřina Jiroutková","Principal Investigator, Kateřina Jiroutková, MD, PhD, EDAIC","100519582","phase-4-oral-care-with-3-hydrogen-peroxide-oroxid-in-icu---effects-on-the-lower-airway-microbial-colonisation-100519582",false,"NCT06045429","Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation","Effects of Oral Care With 3% Hydrogen Peroxide (Oroxid®) on the Lower Respiratory Tract Microbial Colonisation in Mechanically Ventilated Adult Critically Ill Patients (HyPer-MICROBE Trial); a Single-centre, Randomised, Controlled Trial","HyperMICROBE","Inclusion Criteria:\n\n1. Age ≥18 years\n2. In-patient of ICU and expected to stay \\> 5 days\n3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h\n4. Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline\n5. No history and symptoms of aspiration at the baseline\n\nExclusion Criteria:\n\n1. ATB therapy of respiratory infection on admission\n2. Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation\n3. Pregnancy\n4. Oral ulcers or injuries\n5. Patient with a history of hydrogen peroxide allergy","ALL","18 Years",{"count":83,"type":84},160,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult critically ill patients.",[90],"VAP - Ventilator Associated Pneumonia",[92,93,94,95],"pneumonia","hydrogen peroxide","chlorhexidine","respiratory tract microbiome","2024-07-25",{"date":98,"type":99},"2024-07-26","ACTUAL",{"date":101,"type":99},"2024-05-01",{"date":103,"type":84},"2025-12",{"name":5,"class":6},1]