Azithromycin for Critical Asthma - Pediatrics
Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 3 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how azithromycin, an antibiotic, affects the immune system in children with very severe asthma. It is for children ages 3–17 who are in a pediatric intensive care unit (PICU).
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 3–17 years.
- Admitted to the pediatric intensive care unit (PICU).
- Very severe asthma is the main diagnosis.
- Prescribed beta-agonist medicine to open the airways, given nonstop by breathing it in, through a vein (IV), or both.
- Prescribed steroids through a vein (IV) to reduce swelling in the airways.
Who can't join
- A serious heart problem present at birth that has not been repaired.
- Needs a breathing tube through an opening in the neck when admitted.
- Currently taking azithromycin or another antibiotic in the macrolide group for any reason.
- A history of long QT syndrome (a problem with the heart’s electrical signals) or an abnormal heartbeat.
- Another lung condition, including acute chest syndrome (a serious lung problem), interstitial lung disease (lung scarring or swelling), cystic fibrosis (a disease that causes thick mucus), or pulmonary hypertension (high blood pressure in the lungs).
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
FL
- Johns Hopkins All Children's Hospital · St. Petersburg, FL 33701Anthony A Sochet, MD · Study contact · 727-767-2912 · sochet@jhmi.eduMore trials in St. Petersburg