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Azithromycin for Critical Asthma in Children

This study is looking at how Azithromycin, an antibiotic, affects children aged 3 to 17 who are in the intensive care unit (PICU) because of a severe asthma attack. Researchers want to see if Azithromycin can change the body's immune response in these children. You might be able to join if you are in the PICU for critical asthma and are already receiving certain asthma treatments. The main goals are to measure levels of a biomarker called periostin in the blood and to track any side effects from Azithromycin. The study aims to enroll 100 participants.

Study design
This is an interventional study with a planned enrollment of 100 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored during hospitalization, approximately 3 days. Periostin levels will be measured at 24, 48, and 72 hours after enrollment.

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NCT06223828

Azithromycin for Critical Asthma - Pediatrics

Recruiting
PHASE2Ages 3–17InterventionalTreatment
Johns Hopkins All Children's Hospital
~100 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Azithromycin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
Measured over 24 hours, 48 hours, and 72-hours following enrollment
+1 more outcome measured

Conditions

Pediatric Asthma
Critical Illness

Explore related trials

Asthma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Anthony A Sochet, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins All Children's Hospital

Who to contact

Anthony A Sochet, MD
[email protected]
727-487-3711
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint24 hours, 48 hours, and 72-hours following enrollment

    ng/dL

  • Drug-related adverse event rate (Primary Safety Endpoint)During hospitalization, approximately 3 days

    cumulative incidence rate