Azithromycin for Critical Asthma - Pediatrics

Phase 2

Recruiting

• Conditions: Pediatric Asthma; Critical Illness
• Interventions: Drug: Azithromycin

• Registration Number: NCT06223828
• Lead Sponsor: Johns Hopkins All Children's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Study Start: 2024-04-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin Intervention	Azithromycin	Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States