Azithromycin for Critical Asthma - Pediatrics (CR-AZI Kids)

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

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

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Pediatric Asthma
• Intervention / Treatment: Drug: Azithromycin

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Anthony A Sochet, MD; Phone Number: 727-487-3711; Email: Sochet@jhmi.edu
• Study Contact Backup: Name: Alexa R Roberts, MD; Phone Number: 602-526-4397; Email: arober77@jhmi.edu

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • Recruiting
      • Johns Hopkins All Children's Hospital
      • Contact: Anthony A Sochet, MD; Phone Number: 727-767-2912; Email: sochet@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin Intervention; Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.	Drug: Azithromycin; 10mg/kg/dose (max dose 500mg) once daily for 3 days; Other Names: Zithromax
No Intervention: Standard Care; Participants will receive standard care without Azithromycin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint	ng/dL	24 hours, 48 hours, and 72-hours following enrollment
Drug-related adverse event rate (Primary Safety Endpoint)	cumulative incidence rate	During hospitalization, approximately 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (Secondary Clinical Efficacy Endpoint)	Measured in Days, from Hospitalization in ICU through Discharge from ICU	During hospitalization, approximately 3 days
Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)	Measured in Hours from ICU hospitalization through discharge	During hospitalization, approximately 3 days
Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)	Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge	During hospitalization, approximately 3 days
Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)	Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit	Enrollment, Day 1, Day 2, Day 3, at ICU Discharge

Collaborators and Investigators

• Sponsor: Johns Hopkins All Children's Hospital
• Investigators: Principal Investigator: Anthony A Sochet, MD, Johns Hopkins All Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Organic Chemicals; Macrolides; Lactones; Erythromycin; Polyketides; Azithromycin
• Other Study ID Numbers: CR-AZI; IRB00410054 (Other Identifier: Johns Hopkins University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No