Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Key facts
- Where
- Aarhus N, Hellerup, and Kolding, DenmarkSee the 3 sites
- Phase
- Phase 2
Where in Denmark
- Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
- Gentofte HospitalHellerup, DenmarkTaking people
- Lillebaelt HospitalKolding, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen Studies on Asthma in Childhood
- Trial code
- NCT05028153EU 2024-512605-29-01
- Record updated
- 13 April 2025
- Original description
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.Read full original descriptionShow less
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
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.
Inclusion: 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: Known allergy to macrolide antibiotics; Known renal impairment; Known with neurological or psychiatric diseases; Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure; Known with congenital or documented acquired QT interval; Known impaired liver function; 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).