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

RecruitingPhase 4Ages 9 Months - 36 MonthsAllHelse Stavanger HF
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In plain words

What the trial is, and whether it could suit you

The AMIC study is a double-blind, placebo-controlled, multicenter, nationwide, randomized controlled academic pharmaceutical trial. OVERALL PRIMARY OBJECTIVES: * To study the clinical efficacy of antibiotics in children with chronic wet cough (CWC). * To study if duration of treatment with antibiotics in children with CWC has impact on efficacy or time to relapse of symptoms. OVERALL SECONDARY OBJECTIVE: -To study respiratory pathogens and the diversity/composition of airway and gut microbiome in children with CWC compared to healthy controls, and changes in pathogens/microbiome after treatment with antibiotics. OVERALL TERTIARY OBJECTIVE: -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. The study will include two different RCTs AMIC 1

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 9 and \< 36 months. 2. Body weight ≥ 7 kg and \< 24 kg. 3. Born term with Gestational age ≥ 37 weeks. 4. 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. 5. Written informed consent obtained from both parents at inclusion. 6. The study subject must be assessed as eligible for treatment with Augmentin. Exclusion Criteria: 1. Gestational age \< 37 weeks. 2. History of acute upper or lower airway infection the last 2 weeks. 3. History of other viral or bacterial infections the last 2 weeks. 4. Episode with temperature above 38 °C during the last 2 weeks. 5. Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia. 6. Cardiac disease, except persisting foramen ovale or ductus arteriosus. 7. Severe feeding problems/aspiration. 8. Gastroesophageal reflux suspicion or confirmed by ph measurement. 9. Suspicion of hypertrophic tonsils or adenoids 10. Episodes of bronchopulmonary obstruction suggesting asthma 11. Presence of gross neurodevelopmental delay, or suspicion of neurological disease. 12. History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam. 13. Episodes with haemoptysis and with unknown cause. 14. Radiographic changes other than perihilar changes confirmed by x-ray at screening. 15. At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest. 16. Parents unable to speak and/or understand Norwegian language. 17. Received systemic antibiotics within the last 6 months before inclusion. 18. Participation in another clinical intervention trial.
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What it tests

  • Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
  • Placebo
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Where

7 sites
Ålesund Hospital
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Akershus University Hospital
Lillestrøm, Norway
Oslo University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North-Norway
Tromsø, Norway
Trondheim University Hospital
Trondheim, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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