Phase
Condition
Bronchitis
Treatment
Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
Placebo
Clinical Study ID
Ages 9-36 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
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 scorelast 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
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, primaryciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagusatresia.
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 anyother 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.
Study Design
Study Description
Connect with a study center
Haukeland University Hospital
Bergen,
NorwayActive - Recruiting
Akershus University Hospital
Lillestrøm,
NorwayActive - Recruiting
Oslo University Hospital
Oslo,
NorwayActive - Recruiting
Stavanger University Hospital
Stavanger, 40
NorwayActive - Recruiting
University Hospital of North-Norway
Tromsø,
NorwayActive - Recruiting
Trondheim University Hospital
Trondheim,
NorwayActive - Recruiting
Ålesund Hospital
Ålesund,
NorwayActive - Recruiting
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