Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Childhood Asthma With Acute Exacerbation

In brief

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.

Key facts

Study ID

NCT05028153

Run by

Copenhagen Studies on Asthma in Childhood

People needed

320

Starts

2022-11-14

Expected to finish

2032-11-13

Last updated by the study team

2025-04-13

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University Hospital of Copenhagen — Gentofte Municipality, Denmark (enrolling)

Full record on ClinicalTrials.gov

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