Antibiotics, Microbiology and Immunology in Children with Chronic wet Cough - the AMIC study - AMIC 002

Stavanger University Hospital0 个研究点目标入组 350 人开始时间: 2022年12月12日最近更新: 2024年7月22日

试验速览

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•Age > 9 and younger than 36 months., Body weight > 7 kg - < 24 kg, Born term with Gestational age > 37 weeks., Chronic wet cough for > 4 weeks at screening and in addition average cough score last 7 days at inclusion = 4 points and without signs of another cause.Registration = 5 days is mandatory., Written informed consent obtained from both parents at inclusion., The study subject must be assessed as eligble for treatment with Augmentin.

•Gestational age < 37 weeks, Episodes of bronchopulmonary obstruction suggesting asthma, Presence of gross neurodevelopmental delay, or suspicion of neurological disease., History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam., Episodes with haemoptysis and with unknown cause., Radiographic changes other than perihilar changes confirmed by x-ray at screening., At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest., Parents unable to speak and/or understand Norwegian language., Received systemic antibiotics within the last 6 months before inclusion., Participation in another clinical intervention trial., History of acute upper or lower airway infection the last 2 weeks., History of other viral or bacterial infections the last 2 weeks., Episode with temperature above 38 °C during the last 2 weeks., Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia., Cardiac disease, except persisting foramen ovale or ductus arteriosus., Severe feeding problems/aspiration., Gastroesophageal reflux suspicion or confirmed by ph measurement., Suspicion of hypertrophic tonsils or adenoids

发起方

Stavanger University Hospital