The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these. The study hypothesis is: ● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
320
10 mg/kg for 3 consecutive days
Placebo mixture containing no active substance
University Hospital of Copenhagen
Gentofte Municipality, Denmark
RECRUITINGDuration in days of the asthma-like episode from the start of randomization.
Number of days based on a diary.
Time frame: 1-30 days
Change in symptom score.
Using a previously validated symptom scoring model based on a diary. The score range is from 0 (no symptoms) and up to 3 (depending on presence of one or more of the followings symptoms: Cough, breathlessness and wheezing).
Time frame: From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.
Effect modification in relation to the child's respiratory microbiota profile.
Airway microbiota, pathogenic bacteria and vira as measured by 16S-rRNA and whole genome sequencing.
Time frame: Sample time, day 1
Effect modification in relation to the child's respiratory immunological profile.
Evaluation of immune mediator profiles (cytokine and chemokine levels) in the upper airway epithelial lining fluid.
Time frame: Sample time, day 1
The length of hospitalization (days)
Determined by participants medical record.
Time frame: 1-30 days
Need for SABA during the asthma-like episode
Number of days based on a diary.
Time frame: 1-30 days
Need for oral corticosteroids (OCS) during the asthma-like episode.
Number of days based on a diary.
Time frame: 1-30 days
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Stratification of the above analyzes.
On the basis of the presence or absence of bacteria/microbiota in the respiratory tract, based on outcomes 3, 4 and 5.
Time frame: Sample time, day 1
Number of days away from daycare offers.
Number of days based on a diary.
Time frame: 1-30 days
Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s)
The number of days home from daycare causing parent absenteeism due to illness based on this diary registration.
Time frame: 1-30 days
Gut microbiome profile
Occurrence, diversity and abundance of gut microbiota using 16S rRNA sequencing and whole genome sequencing.
Time frame: 1-30 days
Resistance profiles
Occurrence, diversity and abundance of antibiotic resistance genes as assessed by metagenome sequencing.
Time frame: 1-30 days
Adverse Event (AE) registration
Number of events and type of event based on a diary.
Time frame: 1-30 days