Actively Recruiting
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Led by Helse Stavanger HF · Updated on 2024-12-27
350
Participants Needed
7
Research Sites
245 weeks
Total Duration
On this page
Sponsors
H
Helse Stavanger HF
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 9 months to less than 36 months
- Body weight between 7 kg and less than 24 kg
- Born at term with gestational age 37 weeks or more
- Chronic wet cough lasting more than 4 weeks with an average cough score of 4 or higher in the last 7 days
- Written informed consent obtained from both parents
- Eligible for treatment with Augmentin as assessed by the study team
You will not qualify if you...
- Born before 37 weeks of gestation
- Acute upper or lower airway infection within the last 2 weeks
- Other viral or bacterial infections within the last 2 weeks
- Fever above 38 degrees Celsius within the last 2 weeks
- Diagnosed chronic lung diseases such as cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, asthma, immunodeficiency, or esophagus atresia
- Cardiac disease except for persisting foramen ovale or ductus arteriosus
- Severe feeding problems or aspiration
- Suspected or confirmed gastroesophageal reflux
- Suspicion of enlarged tonsils or adenoids
- Episodes suggesting asthma
- Gross neurodevelopmental delay or suspected neurological disease
- Known or suspected allergy to amoxicillin-clavulanate or other betalactams
- Episodes of unexplained coughing up blood
- Radiographic changes other than perihilar changes on screening x-ray
- Signs of digital clubbing, low oxygen, chest deformity, or breathing difficulty at rest
- Parents unable to speak or understand Norwegian
- Systemic antibiotic use within the last 6 months
- Participation in another clinical intervention trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Ålesund Hospital
Ålesund, Norway
Actively Recruiting
2
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
3
Akershus University Hospital
Lillestrøm, Norway
Actively Recruiting
4
Oslo University Hospital
Oslo, Norway
Actively Recruiting
5
Stavanger University Hospital
Stavanger, Norway, 40
Actively Recruiting
6
University Hospital of North-Norway
Tromsø, Norway
Actively Recruiting
7
Trondheim University Hospital
Trondheim, Norway
Actively Recruiting
Research Team
K
Knut Øymar, MD PhD
CONTACT
I
Ingvild B Mikalsen, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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