Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms (NCT05028153) | Clinical Trial Compass
RecruitingPhase 2
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
Denmark320 participantsStarted 2022-11-14
Plain-language 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.
Who can participate
Age range12 Months – 71 Months
SexALL
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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).
What they're measuring
1
Duration in days of the asthma-like episode from the start of randomization.