Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study

Study populations:

AMIC 1:

90 children with chronic wet cough aged 9-36 months.

AMIC 2:

210 children with chronic wet cough aged 9-36 months.

All children will be followed until 24 months after the start of the Randomized Controlled Trial (RCT).

HEALTHY CONTROL GROUP:

To study the role of respiratory pathogens, airway and gut microbiome, inflammation and immunology, 50 healthy controls will be included for comparison to AMIC 1. The healthy controls will have a second visit 6 months after inclusion.

Inclusion criteria

• Age ≥ 9 and < 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. Registration ≥ 5 days is mandatory.
• Written informed consent obtained from both parents at inclusion.
• The study subject must be assessed as eligible for treatment with Augmentin.

Exclusion criteria

• Gestational age < 37 weeks.
• 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
• 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.