Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

• Status: Not yet recruiting
• Trial end date: 2031-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen Studies on Asthma in Childhood
• Treatments: Azithromycin

Criteria

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).