Status:
RECRUITING
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
Oslo University Hospital
Haukeland University Hospital
Conditions:
Protracted Bacterial Bronchitis
Eligibility:
All Genders
9-36 years
Phase:
PHASE4
Brief Summary
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 an...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06020716
Start Date
August 16 2023
End Date
April 30 2028
Last Update
December 27 2024
Active Locations (7)
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1
Ålesund Hospital
Ålesund, Norway
2
Haukeland University Hospital
Bergen, Norway
3
Akershus University Hospital
Lillestrøm, Norway
4
Oslo University Hospital
Oslo, Norway