Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-71
SponsorCopenhagen Studies on Asthma in Childhood
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
The child is between 12-71 months old.
Fluent Danish skills with parents / guardians.
Disqualifiers
Known allergy to macrolide antibiotics.
Known impaired liver function.
Known renal impairment.
Known with neurological or psychiatric diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Azithromycin Oral Liquid Product
Drug10 mg/kg for 3 consecutive days
Placebo mixture
Other interventionPlacebo mixture containing no active substance
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: AntibioticsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration in days of the asthma-like episode from the start of randomization.
Number of days based on a diary.
Time frame
1-30 daysSecondary outcomes
1
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.2
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 13
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 14
The length of hospitalization (days)
Determined by participants medical record.
Time frame
1-30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov