Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 3 to 17

Using Azithromycin to treat critical asthma in children

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

Run by Johns Hopkins All Children's Hospital · NCT06223828 · Data updated 2026-11-12

This study is testing if the antibiotic Azithromycin can help children aged 3-17 with severe asthma feel better by reducing inflammation while they are in the hospital.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages3 Years to 17 Years
SexAll
Enrollment100 (estimated)
SponsorJohns Hopkins All Children's Hospital
Academic / other
Locations1 site (St. Petersburg, Florida)
StatusRecruiting
StartedApril 2, 2024
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedAugust 11, 2026
Trial IDNCT06223828 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 3-17 years who are admitted to the PICU with a primary diagnosis of critical asthma.

Probably not a fit

Patients with critical congenital heart disease, tracheostomy dependence, or other significant respiratory pathologies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CR-AZI Study investigates the effects of Azithromycin, a macrolide antibiotic, on the immune response in pediatric patients suffering from critical asthma. This interventional study will assess children aged 3-17 years who are hospitalized in the PICU with a primary diagnosis of critical asthma and are receiving standard treatments like inhaled or intravenous beta-agonists and systemic corticosteroids. The researchers aim to measure levels of a specific inflammatory biomarker, periostin, to determine if Azithromycin can lower these levels compared to those not receiving the drug. Additionally, the study will evaluate the safety of Azithromycin by monitoring adverse events and examining clinical efficacy markers.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that improves outcomes for children with critical asthma.

How similar studies have gone: While the use of Azithromycin in respiratory conditions has been explored, its application specifically for pediatric critical asthma is novel and has not been extensively studied.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Anthony A Sochet, MD — Johns Hopkins All Children's Hospital
  • Study coordinator: Anthony A Sochet, MD
  • Email: Sochet@jhmi.edu
  • Phone: 727-487-3711

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.