Azithromycin for Critical Asthma - Pediatrics

NCT06223828 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CR-AZIIRB00410054
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Asthma; Critical Illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Length of Stay (Secondary Clinical Efficacy Endpoint)

  During hospitalization, approximately 3 days

• Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)

  During hospitalization, approximately 3 days

• Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)

  During hospitalization, approximately 3 days

• Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)

  Enrollment, Day 1, Day 2, Day 3, at ICU Discharge

Study Arms (2)

Azithromycin Intervention

EXPERIMENTAL

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

Drug: Azithromycin

Standard Care

NO INTERVENTION

Participants will receive standard care without Azithromycin.

Interventions

Azithromycin DRUG

10mg/kg/dose (max dose 500mg) once daily for 3 days

Also known as: Zithromax

Azithromycin Intervention

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Anthony A Sochet, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony A Sochet, MD

CONTACT

727-487-3711; Sochet@jhmi.edu

Alexa R Roberts, MD

CONTACT

602-526-4397; arober77@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will be enrolled into either a single interventional arm or a parallel standard care arm.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)