Azithromycin treatment for hospitalized children with asthma symptoms
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
This study is testing if a three-day treatment with azithromycin can help young children in the hospital with asthma symptoms feel better faster compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 12 Months to 71 Months |
| Sex | All |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 1 site (Gentofte Municipality) |
| Trial ID | NCT05028153 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a three-day azithromycin treatment compared to a placebo in children aged 1-5 years who are hospitalized due to asthma-like symptoms. The study includes children with a history of previous asthmatic episodes and aims to replicate earlier findings that suggested azithromycin can shorten the duration of these episodes. By focusing on individual responses to treatment, the study hopes to contribute to personalized asthma management based on the child's respiratory microbiome and immunological profile. The ultimate goal is to enhance understanding of bacterial influences on asthma in preschool children and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-5 years with a history of asthma-like symptoms and currently receiving SABA treatment.
Not a fit: Patients with known allergies to macrolide antibiotics or significant comorbidities such as liver or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the duration and severity of asthma episodes in young children.
How similar studies have performed: Previous studies have shown promising results with azithromycin in treating asthma-like symptoms, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Gentofte Municipality
- University Hospital of Copenhagen — Gentofte Municipality, Denmark (Recruiting)
Study contacts
- Principal investigator: Jakob Stokholm, MD, PhD — University Hospital of Copenhagen, DK-2820 Gentofte, Denmark
- Study coordinator: Klaus Bønnelykke, MD, PhD
- Email: kb@copsac.com
- Phone: +4538677360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.