Azithromycin for Critical Asthma - Pediatrics

Phase 3RecruitingNCT06223828

Johns Hopkins All Children's Hospital100 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Pediatric Asthma Critical Illness

Interventions

AzithromycinDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint

ng/dL

Time frame: 24 hours, 48 hours, and 72-hours following enrollment

Drug-related adverse event rate (Primary Safety Endpoint)

cumulative incidence rate

Time frame: During hospitalization, approximately 3 days

Secondary Outcomes

Length of Stay (Secondary Clinical Efficacy Endpoint)

Measured in Days, from Hospitalization in ICU through Discharge from ICU

Time frame: During hospitalization, approximately 3 days

Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)

Measured in Hours from ICU hospitalization through discharge

Time frame: 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

Time frame: 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

Time frame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge

Central Contacts

Anthony A Sochet, MD

CONTACT

727-487-3711 Sochet@jhmi.edu

Alexa R Roberts, MD

CONTACT

602-526-4397 arober77@jhmi.edu

Data from ClinicalTrials.gov

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