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Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Sponsor: Helse Stavanger HF
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.
Official title: A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough.
Key Details
Gender
All
Age Range
9 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2023-08-16
Completion Date
2028-04-30
Last Updated
2024-12-27
Healthy Volunteers
Yes
Conditions
Interventions
Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
Three times daily
Placebo
Three times daily
Locations (7)
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