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

Protracted Bacterial Bronchitis Clinical Trial

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.

Status Recruiting

Clinical Trial 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 inflammatory markers in children with CWC and the impact of treatment with antibiotics. Furthermore, identify children with CWC who have primary immunodeficiency (PID) based on functional laboratory markers and genetic markers of PID.

The study will include two different interventions:

INTERVENTION 1:

Participants will be randomly assigned to 14 days antibiotics or placebo

INTERVENTION 2:

Participants will be randomly assigned 1:1 to receive either 14 or 28 days with amoxicillin-clavulanate syrup

Clinical Trial Description

Study populations:

INTERVENTION 1:

90 children with chronic wet cough aged 9-36 months

INTERVENTION 2:

210 children with chronic wet cough aged 9-26 months

Both intervention groups 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, inflammatory markers and immunodeficiency, 50 healthy controls will be included for comparison to IV 1. The healthy controls will be followed for 6 months after inclusion. ;

Related Conditions & MeSH terms

• Bronchitis
• Protracted Bacterial Bronchitis

• NCT number: NCT06020716
• Study type: Interventional
• Source: Helse Stavanger HF
• Contact: Knut Øymar, MD PhD
• Phone: +47 41633426
• Email: knut.oymar@sus.no
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2023
• Completion date: April 30, 2028