[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553646":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":41,"collaborators":46,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":34,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":34},{"fullName":5,"class":6},"University Hospital Fattouma Bourguiba","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"colistin group","ACTIVE_COMPARATOR","Colistin group:\n\nIn the Nebulized colistimethate sodium (CMS) group, 100 000 IU\u002Fkg of CMS (equivalent to 0.96 mg\u002Fkg of colistin base), will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 2 million of IU is reconstituted in 6mL of sterile 0.9% saline. The adequate volume is then withdrawn and compleated by 0.9% saline to reach a total volume of 6 ml that is administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty.\n\nThe nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for a maximum of 7 days or until extubation (whichever occurres first).\n\n\\*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base.",[13],"Drug: colistimethate sodium",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty.",[19],"Drug: 0.9% Saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","colistimethate sodium","100 000 IU\u002Fkg of colistimethate sodium (equivalent to 0.96 mg\u002Fkg of colistin base) , will be nebulized daily, divided into two doses for a maximum of 7 days for eligible ventilated children starting from day 3 of mechanical ventilation.",[9],[27],"Colistin",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"0.9% Saline","Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 7 days from day 3 of invasive mechanical ventilation for eligibile ventilated children",[15],[33],"normal saline",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Farah C Thabet, MD","CONTACT","0021629742011","thabetfarah@yahoo.fr",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":45,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Farah Thabet","PROFESSOR IN PEDIATRICS","University of Monastir",[47,50,52,54,56,58,60,62,64,66,68,70,72,74],{"name":48,"class":49},"the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia","UNKNOWN",{"name":51,"class":49},"University General hospital of Larissa, University of Thessaly, Larissa, Greece",{"name":53,"class":49},"Cukurova University School of Medicine, Adana, Turquey",{"name":55,"class":6},"University General Hospital of Heraklion",{"name":57,"class":49},"Osmangazi University School of Medicine, Eskişehir, Turkey",{"name":59,"class":6},"Aghia Sophia Children's Hospital of Athens",{"name":61,"class":6},"Athens General Children's Hospital \"Pan. & Aglaia Kyriakou\"",{"name":63,"class":6},"Attikon Hospital",{"name":65,"class":49},"Gazi University School of Medicine, Ankara, Turquey",{"name":67,"class":49},"Cerrahpaşa University School of Medicine, Istambul, Turquey",{"name":69,"class":49},"Marmara University School of Medicine, Istambul, Turquey",{"name":71,"class":49},"Başakşehir Çam ve Sakura Hospital, Istambul, Turquey",{"name":73,"class":49},"Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco",{"name":75,"class":49},"Hadi Cheker university hospital, sfax, Tunisia","100553646","phase-2-nebulised-colistimethate-sodium-to-prevent-pediatric-ventilator-associated-pneumonia-100553646",false,"NCT06488794","Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia","Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation","ColiPed","Inclusion Criteria:\n\n* Children older than 1 month and younger than 14 years\n* Patients on invasive mechanical ventilation for more than 48 hours\n* Informed parental consent\n\nExclusion Criteria:\n\n* Suspected or confirmed VAP on the day of inclusion\n* Indication for systemic colistin therapy before or at enrolment in the study\n* Plan for extubation within the next 24H\n* Known allergy to colistin\n* No parental consent\n* Tracheostomy\n* Appearance of allergic clinical manifestations in the days of colistin nebulization\n* Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin","ALL","1 Month","14 Years",{"count":88,"type":89},400,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE2","PHASE3","The goal of this clinical trial is to learn if nebulized colistimethate sodium can prevent pneumonia in ventilated children. The main question it aims to answer is:\n\n• Does nebulized colistimethate sodium lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistimethate sodium to a placebo (a look-alike substance that contains no drug) to see if nebulized colistin works to prevent ventilation associated pneumonia in children.\n\nParticipants will:\n\n* Take nebulized colistimethate sodium or a placebo twice a day for a maximum of 7 days.\n* Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.",[96],"Ventilator Associated Pneumonia",[98,99,100,101,102,103],"colistin","mechanical ventilation","pneumonia","nebulization","prevention","pediatrics","NOT_YET_RECRUITING","2026-02-20",{"date":107,"type":108},"2026-02-24","ACTUAL",{"date":110,"type":89},"2027-01-01",{"date":112,"type":89},"2028-12-31",{"name":5,"class":6}]