Azithromycin for Critical Asthma - Pediatrics

Critical Illness Clinical Trial

— CR-AZI Kids  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223828
• Other study ID #: CR-AZI
• Secondary ID: IRB00410054
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins All Children's Hospital
• Contact: Anthony A Sochet, MD
• Phone: 727-487-3711
• Email: Sochet[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Critical Illness
• Pediatric Asthma

Intervention

Drug:
• Azithromycin
10mg/kg/dose (max dose 500mg) once daily for 3 days

Locations

Country	Name	City	State
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins All Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Drug-related adverse event rate (Primary Safety Endpoint)	cumulative incidence rate	During hospitalization, approximately 3 days
Secondary	Length of Stay (Secondary Clinical Efficacy Endpoint)	Measured in Days, from Hospitalization in ICU through Discharge from ICU	During hospitalization, approximately 3 days
Secondary	Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)	Measured in Hours from ICU hospitalization through discharge	During hospitalization, approximately 3 days
Secondary	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
Secondary	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