Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking

ID
Name
CR-AZI
Description
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Trial arms
Trial start
2024-04-02
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Azithromycin
10mg/kg/dose (max dose 500mg) once daily for 3 days
Arms:
Azithromycin Intervention
Other names:
Zithromax
Size
100
Primary endpoint
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
24 hours, 48 hours, and 72-hours following enrollment
Drug-related adverse event rate (Primary Safety Endpoint)
During hospitalization, approximately 3 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Children will be enrolled into either a single interventional arm or a parallel standard care arm.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-19

1 organization

1 product

2 indications

Organization
Johns Hopkins All Children's Hospital
Product
Azithromycin
Indication
Pediatric Asthma
Indication
Critical Illness