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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Active Comparator | Azithromycin (10mg/kg) administered via oral suspension for 3 consecutive days |
|
| Placebo | Placebo Comparator | Placebo with no active substance administered via oral suspension for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin Oral Liquid Product | Drug | 10 mg/kg for 3 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration in days of the asthma-like episode from the start of randomization. | Number of days based on a diary. | 1-30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom score. | Using a previously validated symptom scoring model based on a diary. The score range is from 0 (no symptoms) and up to 3 (depending on presence of one or more of the followings symptoms: Cough, breathlessness and wheezing). | From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus Bønnelykke, MD, PhD | Contact | +4538677360 | kb@copsac.com | |
| Ulrik Ralfkiaer, MSc, PhD | Contact | +4538674164 | administration@dbac.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jakob Stokholm, MD, PhD | University Hospital of Copenhagen, DK-2820 Gentofte, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Copenhagen | Recruiting | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35418427 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D007239 | Infections |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo mixture |
| Other |
Placebo mixture containing no active substance |
|
| Effect modification in relation to the child's respiratory microbiota profile. | Airway microbiota, pathogenic bacteria and vira as measured by 16S-rRNA and whole genome sequencing. | Sample time, day 1 |
| Effect modification in relation to the child's respiratory immunological profile. | Evaluation of immune mediator profiles (cytokine and chemokine levels) in the upper airway epithelial lining fluid. | Sample time, day 1 |
| The length of hospitalization (days) | Determined by participants medical record. | 1-30 days |
| Need for SABA during the asthma-like episode | Number of days based on a diary. | 1-30 days |
| Need for oral corticosteroids (OCS) during the asthma-like episode. | Number of days based on a diary. | 1-30 days |
| Stratification of the above analyzes. | On the basis of the presence or absence of bacteria/microbiota in the respiratory tract, based on outcomes 3, 4 and 5. | Sample time, day 1 |
| Number of days away from daycare offers. | Number of days based on a diary. | 1-30 days |
| Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s) | The number of days home from daycare causing parent absenteeism due to illness based on this diary registration. | 1-30 days |
| Gut microbiome profile | Occurrence, diversity and abundance of gut microbiota using 16S rRNA sequencing and whole genome sequencing. | 1-30 days |
| Resistance profiles | Occurrence, diversity and abundance of antibiotic resistance genes as assessed by metagenome sequencing. | 1-30 days |
| Adverse Event (AE) registration | Number of events and type of event based on a diary. | 1-30 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |