NCT05028153RecruitingPhase 2
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 19 Aug 2021
- Start date
- 14 Nov 2022
- Primary completion date
- 13 Nov 2026
- Lead sponsor
- Copenhagen Studies on Asthma in Childhood
- Diseases
- Asthma
- NCT number
- NCT05028153
- EU CT number
- 2024-512605-29-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 320
- From 14 Nov 2022 to the primary completion date, 13 Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Known with congenital or documented acquired QT interval.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 12 months to 71 months · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Gentofte Hospital Coordinator of this site? Confirm its status | Hellerup | Denmark | Recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Kolding | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.