Antibiotics, Microbiology and Immunology in Children With Chronic Wet Couch - the AMIC Study (AMIC)
Protracted Bacterial Bronchitis
About this trial
This is an interventional treatment trial for Protracted Bacterial Bronchitis focused on measuring Chronic wet cough, Antibiotic, Children, Microbiology, Immunology
Eligibility Criteria
Inclusion Criteria: Age > 9 and younger than 36 months. Body weight > 7 kg and < 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 randomization ≥ 4 points and without signs of another cause. Written informed consent obtained from both parents at inclusion. The study subject must be assessed as eligble for treatment with Augmentin. Exclusion Criteria: Gestational age < 37 weeks. History of acute upper or lower airway infection the last 4 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 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 trial.
Sites / Locations
- Stavanger University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Intervention group 1 (IV 1) Arm A
Intervention group 1 (IV 1) Arm B
Intervention group 2 (IV2) Arm C
Intervention group 2 (IV 2) Arm D
In the first Intervention group (IV 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. IV 1 Arm A will receive 14 days amoxicillin-clavulanate syrup..
In the first Intervention group (IV 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. IV 1 Arm B will receive 14 days placebo syrup.
In the second intervention group (IV 2), 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). IV 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo.
In the second intervention group (IV 2), 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). IV 2 Arm D will receive 28 days amoxicillin-clavulanate syrup.