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 and AMIC 2:
AMIC 1:
Participants will be randomly assigned to 14 days amoxicillin-clavulanate syrup or placebo.
AMIC 2:
Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup.
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.
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.
Helse Stavanger HF
Lead sponsor
Oslo University Hospital
Collaborator
Haukeland University Hospital
Collaborator
Alesund Hospital
Collaborator
University Hospital, Akershus
Collaborator
Trondheim University Hospital
Collaborator
University Hospital of North Norway
Collaborator