Actively Recruiting
Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Led by Johns Hopkins All Children's Hospital · Updated on 2025-12-17
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the immune effects of Azithromycin in children hospitalized with critical asthma, a severe asthma attack requiring intensive care. The study focuses on understanding how Azithromycin influences a specific inflammatory marker called periostin in the lungs and assesses its impact alongside standard corticosteroid treatment. It also explores the rates of side effects and differences in clinical and physiological outcomes related to asthma severity. Participants are divided into two groups: one receives Azithromycin at a dose of 10mg per kilogram of body weight once daily for three days, and the other receives standard care without Azithromycin. The study is open-label and non-randomized, with parallel collection of biological samples to analyze inflammatory markers. During the approximately three-day hospital stay, researchers will monitor plasma periostin levels at 24, 48, and 72 hours after enrollment, and track adverse events related to Azithromycin use. Secondary measures include length of hospital stay, duration of continuous albuterol treatment, use of additional asthma therapies, and transcutaneous carbon dioxide levels. This detailed monitoring helps understand treatment effects and safety in critically ill pediatric asthma patients.
CONDITIONS
Brief Title
Azithromycin for Critical Asthma - Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to 17 years
- Admission to the pediatric intensive care unit (PICU)
- Primary diagnosis of critical asthma
- Prescription for continuous inhaled beta-agonist therapy and/or intravenous beta-agonist therapy
- Prescription for intravenous systemic corticosteroids
You will not qualify if you...
- Unrepaired critical congenital heart disease
- Dependence on tracheostomy at admission
- Current use of azithromycin or other macrolide antibiotics
- History of prolonged QT syndrome or heart rhythm problems
- Other respiratory diseases such as acute chest syndrome, interstitial lung disease, cystic fibrosis, or pulmonary hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 days
Participants receive Azithromycin once daily for 3 days or standard care without Azithromycin while hospitalized for critical asthma.
Daily assessments during hospitalization
Duration - Approximately 3 days
Participants are monitored for adverse events and clinical outcomes during hospitalization.
Assessments at 24, 48, and 72 hours post-enrollment
Trial Site Locations
Total: 1 location
1
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
Research Team
A
Anthony A Sochet, MD
A
Alexa R Roberts, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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