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Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

RECRUITINGPhase 2Sponsored by Copenhagen Studies on Asthma in Childhood
Actively Recruiting
PhasePhase 2
SponsorCopenhagen Studies on Asthma in Childhood
Started2022-11-14
Est. completion2026-11-13
Eligibility
Age12 Months – 71 Months
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05028153

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

Age: 12 Months – 71 MonthsHealthy volunteers accepted
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).

Conditions2

AsthmaChildhood Asthma With Acute Exacerbation

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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