Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Status:
RECRUITING
Trial end date:
2028-04-30
Target enrollment:
Participant gender:
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 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.
Phase:
PHASE4
Details
Lead Sponsor:
Helse Stavanger HF
Collaborators:
Alesund Hospital Haukeland University Hospital Oslo University Hospital Trondheim University Hospital University Hospital of North Norway University Hospital, Akershus