[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100243866":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":23,"locations":34,"responsibleParty":47,"collaborators":23,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":23,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":23,"overallStatus":68,"whyStopped":69,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nitazoxanide","ACTIVE_COMPARATOR","Nitazoxanide 7.5mg\u002Fkg oral\u002Fnasogastric\u002Fnasoenteric tube three times per day for five days.",[13],"Drug: Nitazoxanide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The placebo is identical to the active drug described above except that it does not contain the active compound nitazoxanide. It is reconstitutes, administered and dosed as per the active study drug.",[19],"Drug: Placebo (for Nitazoxanide)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG",null,[9],[26],"Alinia",{"type":22,"name":28,"description":23,"armGroupLabels":29,"otherNames":23},"Placebo (for Nitazoxanide)",[15],[31],{"name":32,"affiliation":5,"role":33},"Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil","PRINCIPAL_INVESTIGATOR",[35],{"facility":5,"status":23,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":23},"Perth","Western Australia","6008","Australia","AU",{"type":42,"coordinates":43},"Point",[44,45],115.8614,-31.95224,{"lat":45,"lon":44},{"type":48,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100243866","phase-2-finding-better-treatment-of-bronchiolitis-a-clinical-trial-of-oral-nitazoxanide-for-the-treatment-of-bronchiolitis-in-infants-presenting-to-hospital-emergency-departments-100243866",false,"NCT02452905","Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments","A Phase II Double-blind Randomised, Placebo-controlled Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments","Inclusion Criteria:\n\n* Aged greater than or equal to 1 month to less than or equal to 12 months\n* Diagnosed with bronchiolitis by the assessing doctor\n* Parent\u002Flegally responsible carer has provided informed consent for their infant\u002Fchild to participate in the study\n* Parent\u002Flegally responsible carer able and willing to comply with the requirements of the protocol\n* Parent\u002Flegally responsible carer willing to attend a study follow up visit on study day 3 if their infant\u002Fchild has previously been discharged from hospital\n* Parent\u002Flegally responsible carer willing to allow other parties involved in the treatment of his or her child (including the general practitioner, paediatrician, hospital medical and nursing staff, community clinic staff) to be notified of participation in the trial\n* Infants and children whose parent is willing to allow the study team to obtain an interim medical history from the participants electronic medical records (including immunisation records) and\u002For from the participants general practitioner or other medical professional for the period from enrolment to study day 180\n\nExclusion Criteria:\n\n* Presence of symptoms of bronchiolitis (breathing difficulty, difficulty feeding, cough, poor feeding) for greater than or equal to 48 hours at the time of enrolment\n* Born at gestational age of less than 32 weeks\n* Has a history of any condition associated with risk of severe bronchiolitis including (significant cardiovascular disease, including congenital heart disease, significant respiratory disease including chronic lung disease, Trisomy 21, significant neurological disease including history of seizure disorder, significant impairment\u002Falteration of the immune system including congenital immunodeficiency or any other disorder considered relevant by a medically qualified investigator\n* Requiring admission to intensive care unit at enrolment\n* Clinical suspicion of illness other than bronchiolitis\n* Contraindication to the study drug or placebo (hypersensitivity), medical treatment with medication which in the opinion of the admitting team would make the child unsuitable for the study\n* Receipt of investigational drug\u002Fvaccine, other than the drugs used in the study within 30 days prior to receiving the first dose of NTZ or their planned use during the study period until 1 month after the administration of the final dose of NTZ\n* Previously enrolled in the study\n* Parent less than 18 years of age\n\nTEMPORARY EXCLUSION CRITERIA\n\n* Receipt of an anti-viral medication within the previous 7 days\n* Inability to tolerate either the oral or nasogastric route (e.g. ileus)\n* Any systemic corticosteroid (or equivalent) treatment in 14 days prior to enrolment","ALL","1 Month","12 Months",{"count":60,"type":61},0,"ACTUAL","INTERVENTIONAL",[64],"PHASE2","Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will receive NTZ while the other half will receive a placebo.",[67],"Bronchiolitis","WITHDRAWN","The drug manufacture were unable to produce liquid formulation of the IMP within a reasonable time frame so the funding was relinquished.","2017-10-10",{"date":72,"type":61},"2017-10-12",{"date":74,"type":23},"2016-12",{"date":76,"type":77},"2018-07","ESTIMATED",{"name":5,"class":6},1]