Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azithromycin Oral Liquid Product, Placebo mixture.
- Who it may be relevant to
- Registry conditions: Childhood Asthma With Acute Exacerbation. Basic parameters: 12 months — 71 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
Overview
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.
Detailed description
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
The study hypothesis is:
● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
Interventions
- Drug Azithromycin Oral Liquid Product
10 mg/kg for 3 consecutive days - Other Placebo mixture
Placebo mixture containing no active substance
Primary outcome measures
- Duration in days of the asthma-like episode from the start of randomization. [Time frame: 1-30 days]
Secondary outcome measures (12)
- Change in symptom score. [Time frame: From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.]
- Effect modification in relation to the child's respiratory microbiota profile. [Time frame: Sample time, day 1]
- Effect modification in relation to the child's respiratory immunological profile. [Time frame: Sample time, day 1]
- The length of hospitalization (days) [Time frame: 1-30 days]
- Need for SABA during the asthma-like episode [Time frame: 1-30 days]
- Need for oral corticosteroids (OCS) during the asthma-like episode. [Time frame: 1-30 days]
- Stratification of the above analyzes. [Time frame: Sample time, day 1]
- Number of days away from daycare offers. [Time frame: 1-30 days]
- Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s) [Time frame: 1-30 days]
- Gut microbiome profile [Time frame: 1-30 days]
- Resistance profiles [Time frame: 1-30 days]
- Adverse Event (AE) registration [Time frame: 1-30 days]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- University Hospital of Copenhagen — Gentofte Municipality
Publications
- Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762. PMID 35418427
Identifiers
NCT: NCT05028153 · H-20065249