Actively Recruiting

Phase 2
Age: 12Months - 71Months
All Genders
NCT05028153

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

Led by Copenhagen Studies on Asthma in Childhood · Updated on 2025-04-13

320

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

Who Can Participate

Age: 12Months - 71Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previous episode(s) with asthma-like symptoms and treatment with SABA alone or SABA combined with ICS and possibly LTRA.
  • Parent or guardian agrees to admit the child and follow the trial procedures.
  • Child is between 12 and 71 months old.
  • Parents or guardians have fluent Danish language skills.
Not Eligible

You will not qualify if you...

  • Known allergy to macrolide antibiotics.
  • Known impaired liver function.
  • Known renal impairment.
  • Known neurological or psychiatric diseases.
  • Known congenital or acquired QT interval abnormalities.
  • Known clinically relevant bradycardia, cardiac arrhythmia, or severe heart failure.
  • Clinical signs of pneumonia such as severe tachypnoea (respiratory rate > 50), fever above 39 °C, or elevated C-reactive protein (CRP > 50).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Copenhagen

Gentofte Municipality, Denmark, 2820

Actively Recruiting

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Research Team

K

Klaus Bønnelykke, MD, PhD

CONTACT

U

Ulrik Ralfkiaer, MSc, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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