Using Azithromycin to treat critical asthma in children
Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
This study is testing if the antibiotic Azithromycin can help children aged 3-17 with severe asthma feel better by reducing inflammation while they are in the hospital.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Johns Hopkins All Children's Hospital Academic / other |
| Locations | 1 site (St. Petersburg, Florida) |
| Trial ID | NCT06223828 on ClinicalTrials.gov |
What this trial studies
The CR-AZI Study investigates the effects of Azithromycin, a macrolide antibiotic, on the immune response in pediatric patients suffering from critical asthma. This interventional study will assess children aged 3-17 years who are hospitalized in the PICU with a primary diagnosis of critical asthma and are receiving standard treatments like inhaled or intravenous beta-agonists and systemic corticosteroids. The researchers aim to measure levels of a specific inflammatory biomarker, periostin, to determine if Azithromycin can lower these levels compared to those not receiving the drug. Additionally, the study will evaluate the safety of Azithromycin by monitoring adverse events and examining clinical efficacy markers.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3-17 years who are admitted to the PICU with a primary diagnosis of critical asthma.
Not a fit: Patients with critical congenital heart disease, tracheostomy dependence, or other significant respiratory pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves outcomes for children with critical asthma.
How similar studies have performed: While the use of Azithromycin in respiratory conditions has been explored, its application specifically for pediatric critical asthma is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age 3-17 years * Admission to the PICU * Primary diagnosis of critical asthma * Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy * Prescription for intravenous systemic corticosteroids Exclusion criteria * Critical Congenital Heart Disease Unrepaired * Tracheostomy Dependence at Admission * Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication * Past Medical History of Prolonged QT Syndrome or Arrhythmias * Concomitant respiratory pathology including Acute Chest Syndrome, Interstitial Lung Disease, Cystic Fibrosis, and pulmonary hypertension
Where this trial is running
St. Petersburg, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Anthony A Sochet, MD — Johns Hopkins All Children's Hospital
- Study coordinator: Anthony A Sochet, MD
- Email: Sochet@jhmi.edu
- Phone: 727-487-3711
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.