Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Recruiting · NCT05028153 · Interventional (participants receive a specific treatment) · Lead sponsor: Copenhagen Studies on Asthma in Childhood
View the official record on ClinicalTrials.gov →Interventions studied
Azithromycin Oral Liquid ProductPlacebo mixture
What this trial is about
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.
Who can take part
Age range
12 Months to 71 Months
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Known allergy to macrolide antibiotics.
- Known impaired liver function.
- Known renal impairment.
- Known with neurological or psychiatric diseases.
- Known with congenital or documented acquired QT interval.
- Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
- Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\> 50 and / or Fever: temperature\> 39 °C and / or C-reactive protein (CRP)\> 50).
Where it is running
1 location listed.
- University Hospital of Copenhagen - Gentofte Municipality, Denmark