NCT06020716

Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 9 Months – 36 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study populations: AMIC 1: 90 children with chronic wet cough aged 9-36 months. AMIC 2: 210 children with chronic wet cough aged 9-36 months. All children will be followed until 24 months after the start of the Randomized Controlled Trial (RCT). HEALTHY CONTROL GROUP: To study the role of respiratory pathogens, airway and gut microbiome, inflammation and immunology, 50 healthy controls will be included for comparison to AMIC 1. The healthy controls will have a second visit 6 months after inclusion.

Conditions

• Protracted Bacterial Bronchitis

Interventions

Type	Name	Description
DRUG	Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution	Three times daily
DRUG	Placebo	Three times daily

Timeline

• Start date: 2023-08-16
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2023-09-01
• Last updated: 2024-12-27

Locations

7 sites across 1 country: Norway

Regulatory

• FDA-regulated drug study