Critical Illness, Pediatric Asthma
Conditions
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.
Interventions
DRUGAzithromycin
10mg/kg/dose (max dose 500mg) once daily for 3 days
Sponsors
Johns Hopkins All Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Children will be enrolled into either a single interventional arm or a parallel standard care arm.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Drug-related adverse event rate (Primary Safety Endpoint) | During hospitalization, approximately 3 days | cumulative incidence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (Secondary Clinical Efficacy Endpoint) | During hospitalization, approximately 3 days | Measured in Days, from Hospitalization in ICU through Discharge from ICU |
| Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint) | During hospitalization, approximately 3 days | Measured in Hours from ICU hospitalization through discharge |
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTAnthony A Sochet, MD
CONTACTAlexa R Roberts, MD
PRINCIPAL_INVESTIGATORAnthony A Sochet, MD
Johns Hopkins All Children's Hospital
Outcome results
None listed