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Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

RecruitingPhase 2Ages 12 Months - 71 MonthsAllCopenhagen Studies on Asthma in Childhood
NCT05028153 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Azithromycin Oral Liquid Product
  • Placebo mixture
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Where

1 site
University Hospital of Copenhagen
Gentofte Municipality, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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