[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100288169":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":70,"collaborators":40,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":40,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":45,"whyStopped":40,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Twice a day regimen","EXPERIMENTAL","Patients will received a prescription of amoxicillin (90mg\u002Fkg\u002Fday) divided in two doses daily.",[13],"Drug: Amoxicillin",{"label":15,"type":16,"description":17,"interventionNames":18},"Thrice a day regimen","ACTIVE_COMPARATOR","Patients will received a prescription of amoxicillin (90mg\u002Fkg\u002Fday) divided in three doses daily.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Amoxicillin","(90 mg\u002Fkg\u002Fday) twice daily",[15,9],[26],"Amoxil",[28],{"name":29,"affiliation":30,"role":31},"Jocelyn Gravel, MD","Sainte-Justine Hospital","PRINCIPAL_INVESTIGATOR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","514-345-4931","2559","graveljocelyn@hotmail.com",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Ariane Boutin, MD",null,"arianeboutin@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHU Sainte-Justine","RECRUITING","Montreal","Quebec","H3T1C5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-73.58781,45.50884,{"lat":55,"lon":54},[58,59,60,61,63,66,68],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},{"name":29,"role":31,"phone":40,"phoneExt":40,"email":40},{"name":62,"role":31,"phone":40,"phoneExt":40,"email":40},"Boutin Ariane, MD",{"name":64,"role":65,"phone":40,"phoneExt":40,"email":40},"Benoit Carriere, MD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":40,"phoneExt":40,"email":40},"Marc Lebel, MD",{"name":69,"role":65,"phone":40,"phoneExt":40,"email":40},"Michel Roy, MD",{"type":31,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Jocelyn Gravel","Principal investigator","100288169","phase-2-twice-daily-treatment-with-amoxicillin-for-non-severe-community-acquired-pneumonia-100288169",false,"NCT03031210","Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.","Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.","Inclusion Criteria:\n\n* All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:\n\n  1. Presence of respiratory symptoms (cough and\u002For dyspnea)\n  2. Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)\n  3. Presence of fever\n  4. Positive chest radiography as interpreted by the treating physician\n\nExclusion Criteria:\n\n* Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)\n* History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.\n* History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.\n* Caregiver unable to provide consent (language barrier or lack of caregiver presence)\n* Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)\n* Persistent\u002Fchronic pneumonia syndromes (with symptoms for \\>2 weeks), suspected by the physician to be caused by atypical pathogens, hospital- acquired pneumonia (been hospitalized within 2 weeks prior to enrolment), aspiration pneumonia or recurrent pneumonias.\n* Any history of receiving amoxicillin within the past month\n* Need hospitalisation for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicaemia or meningitis requiring intravenous antimicrobial agents)\n* Previous participation in study",true,"ALL","3 Months","18 Years",{"count":85,"type":86},1370,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE2","PHASE3","The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).",[93],"Community-acquired Pneumonia",[95,96,97],"Non-severe community-acquired pneumonia","Amoxicillin treatment","Twice daily antibiotic regimen","2025-05-13",{"date":100,"type":101},"2025-05-14","ACTUAL",{"date":103,"type":101},"2017-06-11",{"date":105,"type":86},"2027-06-01",{"name":5,"class":6},1]