Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Standard Care
Participants will receive standard care without Azithromycin.
Azithromycin Intervention
Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.
Intervention: Azithromycin (Drug)
Outcomes
Primary Outcomes
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
Time Frame: 24 hours, 48 hours, and 72-hours following enrollment
ng/dL
Drug-related adverse event rate (Primary Safety Endpoint)
Time Frame: During hospitalization, approximately 3 days
cumulative incidence rate
Secondary Outcomes
- Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)(During hospitalization, approximately 3 days)
- Length of Stay (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)