NCT06223828

Azithromycin for Critical Asthma - Pediatrics

Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Johns Hopkins All Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.

Detailed description

Azithromycin (AZI), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 For pediatric critical asthma (CA), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (PICU) hospitalization, the investigator's prior research has revealed 1 in 10 will receive AZI.2 Yet, the application of AZI in this setting is poorly studied nor is clear if, and to what degree AZI alters the immune response in conjunction with systemic corticosteroids traditionally applied in CA. In this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with CA with and without exposure to AZI. The investigators hypothesize children receiving AZI will have lower periostin levels. As a secondary analysis, the investigators will describe the rates of adverse events related to AZI (previously not done) and explore differences in clinical and physiologic CA efficacy markers.

Conditions

• Pediatric Asthma
• Critical Illness

Interventions

Type	Name	Description
DRUG	Azithromycin	10mg/kg/dose (max dose 500mg) once daily for 3 days

Timeline

• Start date: 2024-04-02
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2024-01-25
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study