Recruiting
Azithromycin for Critical Asthma - Pediatrics
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
ClinicalTrials.gov IDNCT06223828
PhasePHASE2, PHASE3
Enrollment100
SponsorJohns Hopkins All Children's Hospital
Age3 Years
SexALL
Conditions studied
Pediatric Asthma, Critical Illness
About this study
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Interventions
- Drug: Azithromycin — 10mg/kg/dose (max dose 500mg) once daily for 3 days
Primary outcomes
- Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint (24 hours, 48 hours, and 72-hours following enrollment)
- Drug-related adverse event rate (Primary Safety Endpoint) (During hospitalization, approximately 3 days)
Eligibility information
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
Study locations
- Johns Hopkins All Children's Hospital, St. Petersburg, Florida 33701 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.