A Phase 4 Study to Evaluate Antibiotic Treatment and Microbiology in Children 9-36 Months With Chronic Wet Cough

What this Trial Is About

Researchers are studying the effects of antibiotics in children aged 9 to 36 months who have chronic wet cough CWC. This study is a phase 4, double-blind, placebo-controlled, randomized trial conducted across multiple centers nationwide. The goals are to understand how effective antibiotics are in treating CWC, whether the length of antibiotic treatment affects recovery or relapse, and to explore the role of respiratory pathogens, microbiomes, inflammation, immunology, and genetics in these children compared to healthy controls. The study consists of two randomized controlled trials, AMIC 1 and AMIC 2. In AMIC 1, 90 children will be randomly assigned to receive either amoxicillin-clavulanate syrup or a placebo syrup for 14 days. In AMIC 2, 210 children will be randomly assigned to receive either 14 days of amoxicillin-clavulanate with 14 days of placebo or a full 28 days of the antibiotic syrup. Additionally, 50 healthy children will be included for comparison and will have two visits spaced six months apart. During the study, children will be followed for up to 24 months after starting treatment to assess response and relapse of symptoms. Researchers will evaluate treatment response 14 days after antibiotic completion and monitor for any relapse up to two years later. Assessments include cough scoring, microbiome analysis from airway and gut samples, and examination of inflammation, immunology, and genetics. The study also involves regular monitoring to ensure safety and adherence to treatment protocols throughout the trial period.

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