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Clinical Trials in Denmark / NCT05028153
Recruiting Phase 2

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

NCT05028153 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen Studies on Asthma in Childhood
Phase
Phase 2
Started
2022-11-14
Last updated
2025-04-13

Condition(s) studied

Childhood Asthma With Acute Exacerbation

Investigational drug(s) / intervention(s)

Azithromycin Oral Liquid ProductPlacebo mixture

Azithromycin Oral Liquid Product: 10 mg/kg for 3 consecutive days

Placebo mixture: Placebo mixture containing no active substance

Study summary

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

Sex
ALL
Min age
12 Months
Max age
71 Months
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Duration in days of the asthma-like episode from the start of randomization. — 1-30 days
    Number of days based on a diary.

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Copenhagen Gentofte Municipality Denmark Recruiting

More Copenhagen Studies on Asthma in Childhood trials in Denmark

High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children Recruiting
Antibiotic Treatment of Recurrent Episodes of Asthma in Children Active, not recruiting
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood Active, not recruiting
Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood Active, not recruiting
A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy Starting soon

Other trials for the same condition

Antibiotic Treatment of Recurrent Episodes of Asthma in Children Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05028153 on ClinicalTrials.gov ↗ ← All trials in Denmark