Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution, Placebo.
- Who it may be relevant to
- Registry conditions: Protracted Bacterial Bronchitis. Basic parameters: 9 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Drug Amoxicillin-Clavulanate 400 Mg-57 Mg/5 mL Oral Powder for Reconstitution
Three times daily - Drug Placebo
Three times daily
Primary outcome measures
- Response to treatment [Time frame: Response to treatment will be assessed 14 days after end of antibiotic treatment]
Secondary outcome measures (1)
- Relapse of symptoms [Time frame: Relapse of symptoms will be assessed up to 24 months after end of antibiotic treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Gestational age < 37 weeks.
- History of acute upper or lower airway infection the last 2 weeks.
- History of other viral or bacterial infections the last 2 weeks.
- Episode with temperature above 38 °C during the last 2 weeks.
- Previous diagnosed with chronic lung disease such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, esophagus atresia.
- Cardiac disease, except persisting foramen ovale or ductus arteriosus.
- Severe feeding problems/aspiration.
- Gastroesophageal reflux suspicion or confirmed by ph measurement.
- Suspicion of hypertrophic tonsils or adenoids
- Episodes of bronchopulmonary obstruction suggesting asthma
- Presence of gross neurodevelopmental delay, or suspicion of neurological disease.
- History of known or suspected allergic reactions to amoxicillin-clavulanate or any other betalactam.
- Episodes with haemoptysis and with unknown cause.
- Radiographic changes other than perihilar changes confirmed by x-ray at screening.
- At examination: Digital clubbing, hypoxia, chest wall deformity, dyspnoea at rest.
- Parents unable to speak and/or understand Norwegian language.
- Received systemic antibiotics within the last 6 months before inclusion.
- Participation in another clinical intervention trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Norway · 7 centers
- Ålesund Hospital — Ålesund
- Haukeland University Hospital — Bergen
- Akershus University Hospital — Lillestrøm
- Oslo University Hospital — Oslo
- Stavanger University Hospital — Stavanger
- University Hospital of North-Norway — Tromsø
- Trondheim University Hospital — Trondheim
Identifiers
NCT: NCT06020716 · AMIC 2023 · 2022-500586-27-00