Clinical trial NCT06223828: Azithromycin for Critical Asthma - Pediatrics
Official title: Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pediatric Asthma
Critical Illness
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be enrolled into either a single interventional arm or a parallel standard care arm.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
timeFrame: 24 hours, 48 hours, and 72-hours following enrollment
measure: Drug-related adverse event rate (Primary Safety Endpoint)
timeFrame: During hospitalization, approximately 3 days
Secondary outcomes:
measure: Length of Stay (Secondary Clinical Efficacy Endpoint)
timeFrame: During hospitalization, approximately 3 days
measure: Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)
timeFrame: During hospitalization, approximately 3 days
measure: Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)
timeFrame: During hospitalization, approximately 3 days
measure: Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)
timeFrame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Anthony A Sochet, MD
role: PRINCIPAL_INVESTIGATOR
References: