Azithromycin for Critical Asthma - Pediatrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Azithromycin.
- Who it may be relevant to
- Registry conditions: Pediatric Asthma, Critical Illness. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Overview
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
- Drug Azithromycin
10mg/kg/dose (max dose 500mg) once daily for 3 days
Primary outcome measures
- 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]
- Drug-related adverse event rate (Primary Safety Endpoint) [Time frame: During hospitalization, approximately 3 days]
Secondary outcome measures (4)
- Length of Stay (Secondary Clinical Efficacy Endpoint) [Time frame: During hospitalization, approximately 3 days]
- Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint) [Time frame: During hospitalization, approximately 3 days]
- Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint) [Time frame: During hospitalization, approximately 3 days]
- Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint) [Time frame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins All Children's Hospital — St. Petersburg
Identifiers
NCT: NCT06223828 · CR-AZI · IRB00410054