[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":136,"collaborators":25,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":25,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The novel care pathway intervention","EXPERIMENTAL","The novel care pathway intervention will incorporate multiple factors to determine risk of bacterial CAP. At recruitment, POC CRP testing, and bioMérieux Spotfire testing of nasopharyngeal swabs (NPS) will identify those who are at appreciable risk and will receive a prescription for antibiotic treatment on day 0. Please refer to the Specimen Collection and Processing manual for more specific information on the collection process. Appreciable-risk participants will be referred back to the clinical team to be given amoxicillin, the current standard of care in Canada (those with penicillin allergy will presumably receive an appropriate substitution as per local guidelines). Low-risk participants will be discharged home without antibiotics.",[13],"Diagnostic Test: The novel care pathway intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management",[19],"Other: Usual Care Alone",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","The pathway uses already-ascertained data, bioMérieux Spotfire testing, and POC CRP testing to stratify patients into risk categories. The first step in the pathway will be POC CRP testing; children with CRP \\> 60 mg\u002FL will be deemed 'appreciable risk', whereas those with CRP \\\u003C 20 mg\u002FL will be deemed 'low risk'. The CRP cut-offs of 20mg\u002FL (more sensitive) and 60mg\u002FL (more specific) were selected after reviewing the literature, with particular emphasis on meta-analyses; other large recent studies have also used 60mg\u002FL as an upper cut-off for bacterial infection. Participants with CRP between 20-60mg\u002FL will be categorized further to identify children either more likely to have bacterial pneumonia or more intolerant of misclassification. 'If they have O2 saturation \\\u003C95% AND tachypnoea as per age-specific norms, they will be 'appreciable risk' (\\>60 bpm for age \\\u003C1 y, \\>50 bpm for 1-2 y, \\>40 bpm for 2-4 y, and \\>30 bpm for \\>4 y).",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care Alone","Participants will be recruited in the ED and will be managed as per the treating clinician; the study team will not influence management.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Jeffrey Pernica, MD","CONTACT","905-521-2100","77577","pernica@mcmaster.ca",[38,59,75,91,106,121],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Alberta Children's hospital","RECRUITING","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":47,"coordinates":48},"Point",[49,50],-114.08529,51.05011,{"lat":50,"lon":49},[53,57],{"name":54,"role":33,"phone":55,"phoneExt":25,"email":56},"Mohamed Eltorki, MD","403-955-7211","mmeltork@ucalgary.ca",{"name":54,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":61,"city":62,"state":42,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Stollery Children's Hospital","NOT_YET_RECRUITING","Edmonton","T6G 2B7",{"type":47,"coordinates":65},[66,67],-113.46871,53.55014,{"lat":67,"lon":66},[70,74],{"name":71,"role":33,"phone":72,"phoneExt":25,"email":73},"Bruce Wright, MD","780-407-8822","Bruce.Wright2@albertahealthservices.ca",{"name":71,"role":58,"phone":25,"phoneExt":25,"email":25},{"facility":76,"status":61,"city":77,"state":78,"zip":79,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"BC Children's Hospital","Vancouver","British Columbia","V6H 3N1",{"type":47,"coordinates":81},[82,83],-123.11934,49.24966,{"lat":83,"lon":82},[86,90],{"name":87,"role":33,"phone":88,"phoneExt":25,"email":89},"Neil Desai, MD","604-875-2345","neil.desai@cw.bc.ca",{"name":87,"role":58,"phone":25,"phoneExt":25,"email":25},{"facility":92,"status":61,"city":93,"state":94,"zip":95,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"McMaster Children's Hospital","Hamilton","Ontario","L8S 4K1",{"type":47,"coordinates":97},[98,99],-79.84963,43.25011,{"lat":99,"lon":98},[102,105],{"name":103,"role":33,"phone":34,"phoneExt":25,"email":104},"April Kam, MD","kama@mcmaster.ca",{"name":103,"role":58,"phone":25,"phoneExt":25,"email":25},{"facility":107,"status":40,"city":108,"state":94,"zip":109,"country":44,"countryCode":45,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Children's Hospital of Eastern Ontario (CHEO)","Ottawa","K1H 8M8",{"type":47,"coordinates":111},[112,113],-75.69812,45.41117,{"lat":113,"lon":112},[116,120],{"name":117,"role":33,"phone":118,"phoneExt":25,"email":119},"Stuart Harman, MD","613-737-7600","sharman@cheo.on.ca",{"name":117,"role":58,"phone":25,"phoneExt":25,"email":25},{"facility":122,"status":61,"city":123,"state":94,"zip":124,"country":44,"countryCode":45,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"The Hospital for Sick Children","Toronto","M5G 1E8",{"type":47,"coordinates":126},[127,128],-79.39864,43.70643,{"lat":128,"lon":127},[131,135],{"name":132,"role":33,"phone":133,"phoneExt":134,"email":25},"Gabrielle Freire, MD","gabrielle.freire@sickkids.ca","416-813-1500",{"name":132,"role":58,"phone":25,"phoneExt":25,"email":25},{"type":137,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Jeffrey Pernica","Associate Professor","100600629","promoting-optimal-treatment-for-community-acquired-pneumonia-in-emergency-rooms-100600629",false,"NCT07099976","PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms","PromotIng Optimal Treatment for Community-acquired PNeumonia in EmErgency Rooms (PIONEERS): a Multicentre, Randomized, Open-labelled, Controlled, Clinical Trial","PIONEERS","Inclusion Criteria:\n\nChildren aged 6 month to 18 years presenting to the Emergency Department who are diagnosed with CAP and are well enough to be discharged home (i.e. 'non-severe' CAP) will be eligible. They must have a fever (on exam or by history) and at least one of:\n\n* Tachypnoea measured at triage (\\>60 bpm for age \\\u003C1, \\>50 for 1-2 years of age, \\>40bpm for 2-4 years of age, and \\>30bpm for \\>4 years of age)\n* Cough on exam or by history\n* Increased work of breathing on exam\n* Auscultatory finding (focal crackles, bronchial breathing, etc.) consistent with CAP\n\nExclusion Criteria:\n\nChildren will be excluded if they have any of the following\n\n* Cystic Fibrosis\n* Anatomic Lung Disease\n* Bronchiectasis\n* Chronic Lung Disease requiring home oxygen or home ventilation\n* Congenital heart Disease (requiring specific medical treatment or with exercise restrictions),\n* History of repeated aspiration\u002Fvelopharyngeal incompetence\n* Malignancy\n* Immunodeficiency (primary, acquired or iatrogenic)\n* Pneumonia previously (clinically) diagnosed within the past month (that was presumed to have resolved prior to the episode prompting the current visit to the ED)\n* Lung abscess within the past 6 months\n* Children who present with ongoing fever after 4 days of amoxicillin, cefprozil, cefuroxime, levofloxacin, moxifloxacin or doxycycline are not eligible; as this duration of therapy with these drugs would normally be sufficient to treat bacterial CAP, a different approach would be required (ie. the care pathway as written might not be appropriate).\n* Children will not be eligible to participate more than once","ALL","6 Months","18 Years",{"count":152,"type":153},698,"ESTIMATED","INTERVENTIONAL",[156],"NA","In North America, up to 5% of preschoolers develop community-acquired pneumonia (CAP) every year. Pneumonia is the second-leading reason for paediatric hospitalization in both Canada and the US; approximately 20% of children hospitalized with CAP may need intensive care, which can result in significant morbidity. Given this burden of disease, it is critical that CAP is managed appropriately. Specific therapy for CAP is dependent on microbiologic aetiology, as bacterial disease will improve with antibiotic treatment.",[159,160],"Community-Acquired Pneumonia (CAP)","Pneumonia",[160,162],"Antibiotics","2026-04-23",{"date":165,"type":166},"2026-04-29","ACTUAL",{"date":168,"type":166},"2026-04-15",{"date":170,"type":153},"2030-05-15",{"name":138,"class":6},6]