The AMIC study

Phase 1

Recruiting

• Conditions: Chronic wet cough in young children; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-500586-27-00
• Lead Sponsor: Stavanger University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified