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.
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 3
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Norway
Ålesund Hospital
RECRUITING
Ålesund
Haukeland University Hospital
RECRUITING
Bergen
Akershus University Hospital
RECRUITING
Lillestrøm
Oslo University Hospital
RECRUITING
Oslo
Stavanger University Hospital
RECRUITING
Stavanger
University Hospital of North-Norway
RECRUITING
Tromsø
Trondheim University Hospital
RECRUITING
Trondheim
Contact Information
Primary
Knut Øymar, MD PhD
knut.oymar@sus.no
+47 41633426
Backup
Ingvild B Mikalsen, MD PhD
ingvild.bruun.mikalsen@sus.no
+47 46892206
Time Frame
Start Date:2023-08-16
Estimated Completion Date:2028-04-30
Participants
Target number of participants:350
Treatments
Experimental: AMIC 1: Arm A
In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (Arm A and B) for 14 days. AMIC 1 Arm A will receive 14 days amoxicillin-clavulanate syrup.
Placebo_comparator: AMIC 1: Arm B
In AMIC 1, 90 children will be randomly be assigned 1:1 to receive either amoxicillin-clavulanate syrup or placebo (arm A and B) for 14 days. AMIC 1 Arm B will receive 14 days placebo syrup.
Experimental: AMIC 2: Arm C
In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm C will receive 14 days amoxicillin-clavulanate syrup and 14 days placebo.
Experimental: AMIC 2: Arm D
In AMIC 2, 210 children will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup (arm C and D). AMIC 2 Arm D will receive 28 days amoxicillin-clavulanate syrup.
Collaborators: University Hospital of North Norway, Haukeland University Hospital, Trondheim University Hospital, Oslo University Hospital, University Hospital, Akershus, Alesund Hospital