[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517682":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":148,"collaborators":150,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":169,"sex":170,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":34,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Helse Stavanger HF","OTHER_GOV",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"AMIC 1: Arm A","EXPERIMENTAL","In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (Arm A and B) for 14 days. AMIC 1 Arm A will receive 14 days amoxicillin-clavulanate syrup.",[13],"Drug: Amoxicillin-Clavulanate 400 Mg-57 Mg\u002F5 mL Oral Powder for Reconstitution",{"label":15,"type":16,"description":17,"interventionNames":18},"AMIC 1: Arm B","PLACEBO_COMPARATOR","In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (arm A and B) for 14 days. AMIC 1 Arm B will receive 14 days placebo syrup.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"AMIC 2: Arm C","In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo.",[13,19],{"label":25,"type":10,"description":26,"interventionNames":27},"AMIC 2: Arm D","In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm D will receive 28 days amoxicillin-clavulanate syrup.",[13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Amoxicillin-Clavulanate 400 Mg-57 Mg\u002F5 mL Oral Powder for Reconstitution","Three times daily",[9,21,25],null,{"type":30,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Placebo",[15,21],[39],{"name":40,"affiliation":5,"role":41},"Knut Øymar, MD PhD","STUDY_CHAIR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":34,"email":46},"CONTACT","+47 41633426","knut.oymar@sus.no",{"name":48,"role":44,"phone":49,"phoneExt":34,"email":50},"Ingvild B Mikalsen, MD PhD","+47 46892206","ingvild.bruun.mikalsen@sus.no",[52,68,80,92,107,124,136],{"facility":53,"status":54,"city":55,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Ålesund Hospital","RECRUITING","Ålesund","Norway","NO",{"type":59,"coordinates":60},"Point",[61,62],6.15492,62.47225,{"lat":62,"lon":61},[65],{"name":66,"role":44,"phone":34,"phoneExt":34,"email":67},"Torbjørn Nag, MD","Torbjorn.Nag@helse-mr.no",{"facility":69,"status":54,"city":70,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Haukeland University Hospital","Bergen",{"type":59,"coordinates":72},[73,74],5.32415,60.39299,{"lat":74,"lon":73},[77],{"name":78,"role":44,"phone":34,"phoneExt":34,"email":79},"Asle Hirt, PhD","asle.hirth@helse-bergen.no",{"facility":81,"status":54,"city":82,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Akershus University Hospital","Lillestrøm",{"type":59,"coordinates":84},[85,86],11.04918,59.95597,{"lat":86,"lon":85},[89],{"name":90,"role":44,"phone":34,"phoneExt":34,"email":91},"Chris Inchley, PhD","Christopher.Stephen.Inchley@ahus.no",{"facility":93,"status":54,"city":94,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Oslo University Hospital","Oslo",{"type":59,"coordinates":96},[97,98],10.74609,59.91273,{"lat":98,"lon":97},[101,104],{"name":102,"role":44,"phone":34,"phoneExt":34,"email":103},"Håvard Skjerven, Professor","uxskjh@ous-hf.no",{"name":105,"role":44,"phone":106,"phoneExt":34,"email":34},"Per Kristian Knudsen, PhD","uxpekn@ous-hf.no",{"facility":108,"status":54,"city":109,"state":34,"zip":110,"country":56,"countryCode":57,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Stavanger University Hospital","Stavanger","40",{"type":59,"coordinates":112},[113,114],5.73332,58.97005,{"lat":114,"lon":113},[117,121],{"name":118,"role":44,"phone":119,"phoneExt":34,"email":120},"Ingvild B Mikalsen, Ass.Prof","+4790203676","miib@sus.no",{"name":122,"role":44,"phone":123,"phoneExt":34,"email":46},"Knut Øymar, Prof","+4741633426",{"facility":125,"status":54,"city":126,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"University Hospital of North-Norway","Tromsø",{"type":59,"coordinates":128},[129,130],18.95508,69.6489,{"lat":130,"lon":129},[133],{"name":134,"role":44,"phone":34,"phoneExt":34,"email":135},"Claus Klingenberg, Professor","Claus.Klingenberg@unn.no",{"facility":137,"status":54,"city":138,"state":34,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Trondheim University Hospital","Trondheim",{"type":59,"coordinates":140},[141,142],10.39506,63.43049,{"lat":142,"lon":141},[145],{"name":146,"role":44,"phone":34,"phoneExt":34,"email":147},"Henrik Døllner, Professor","henrik.dollner@ntnu.no",{"type":149,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[151,153,154,156,158,159],{"name":93,"class":152},"OTHER",{"name":69,"class":152},{"name":155,"class":152},"Alesund Hospital",{"name":157,"class":152},"University Hospital, Akershus",{"name":137,"class":152},{"name":160,"class":152},"University Hospital of North Norway","100517682","phase-4-antibiotics-microbiology-and-immunology-in-children-with-chronic-wet-cough---the-amic-study-100517682",false,"NCT06020716","Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study","A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough.","AMIC","Inclusion Criteria:\n\n1. Age ≥ 9 and \\\u003C 36 months.\n2. Body weight ≥ 7 kg and \\\u003C 24 kg.\n3. Born term with Gestational age ≥ 37 weeks.\n4. Chronic wet cough for \\> 4 weeks at screening and in addition average cough score last 7 days at randomization ≥ 4 points and without signs of another cause. Registration ≥ 5 days is mandatory.\n5. Written informed consent obtained from both parents at inclusion.\n6. The study subject must be assessed as eligible for treatment with Augmentin.\n\nExclusion Criteria:\n\n1. Gestational age \\\u003C 37 weeks.\n2. History of acute upper or lower airway infection the last 2 weeks.\n3. History of other viral or bacterial infections the last 2 weeks.\n4. Episode with temperature above 38 °C during the last 2 weeks.\n5. Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.\n6. Cardiac disease, except persisting foramen ovale or ductus arteriosus.\n7. Severe feeding problems\u002Faspiration.\n8. Gastroesophageal reflux suspicion or confirmed by ph measurement.\n9. Suspicion of hypertrophic tonsils or adenoids\n10. Episodes of bronchopulmonary obstruction suggesting asthma\n11. Presence of gross neurodevelopmental delay, or suspicion of neurological disease.\n12. History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.\n13. Episodes with haemoptysis and with unknown cause.\n14. Radiographic changes other than perihilar changes confirmed by x-ray at screening.\n15. At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.\n16. Parents unable to speak and\u002For understand Norwegian language.\n17. Received systemic antibiotics within the last 6 months before inclusion.\n18. Participation in another clinical intervention trial.",true,"ALL","9 Months","36 Months",{"count":174,"type":175},350,"ESTIMATED","INTERVENTIONAL",[178],"PHASE4","The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial.\n\nOVERALL PRIMARY OBJECTIVES:\n\n* To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC).\n* To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms.\n\nOVERALL SECONDARY OBJECTIVE:\n\n-To study respiratory pathogens and the diversity\u002Fcomposition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens\u002Fmicrobiome after treatment with antibiotics.\n\nOVERALL TERTIARY OBJECTIVE:\n\n-To study the role of inflammation, immunology, and genetics in children with chronic wet cough and suspicion of PBB to increase the knowledge of pathophysiological mechanisms associated with PBB.\n\nThe study will include two different RCTs AMIC 1 and AMIC 2:\n\nAMIC 1:\n\nParticipants will be randomly assigned to 14 days amoxicillin-clavulanate syrup or placebo.\n\nAMIC 2:\n\nParticipants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup.",[181],"Protracted Bacterial Bronchitis",[183,184,185,186,187],"Chronic wet cough","Antibiotic","Children","Microbiology","Immunology","2024-12-20",{"date":190,"type":191},"2024-12-27","ACTUAL",{"date":193,"type":191},"2023-08-16",{"date":195,"type":175},"2028-04-30",{"name":5,"class":6},7]