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NCT Number: NCT06223828

Azithromycin for Critical Asthma - Pediatrics

The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.

Recruiting

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location status: Recruiting

Location contact

Anthony A Sochet, MD

CONTACT

[email protected]

727-767-2912

About this study

Azithromycin (AZI), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 For pediatric critical asthma (CA), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (PICU) hospitalization, the investigator's prior research has revealed 1 in 10 will receive AZI.2 Yet, the application of AZI in this setting is poorly studied nor is clear if, and to what degree AZI alters the immune response in conjunction with systemic corticosteroids traditionally applied in CA.

In this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with CA with and without exposure to AZI. The investigators hypothesize children receiving AZI will have lower periostin levels. As a secondary analysis, the investigators will describe the rates of adverse events related to AZI (previously not done) and explore differences in clinical and physiologic CA efficacy markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

10mg/kg/dose (max dose 500mg) once daily for 3 days

Other names: Zithromax

Primary outcomes

  1. Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint

    Time frame: 24 hours, 48 hours, and 72-hours following enrollment

    ng/dL

  2. Drug-related adverse event rate (Primary Safety Endpoint)

    Time frame: During hospitalization, approximately 3 days

    cumulative incidence rate

Secondary outcomes

  1. Length of Stay (Secondary Clinical Efficacy Endpoint)

    Time frame: During hospitalization, approximately 3 days

    Measured in Days, from Hospitalization in ICU through Discharge from ICU

  2. Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)

    Time frame: During hospitalization, approximately 3 days

    Measured in Hours from ICU hospitalization through discharge

  3. Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)

    Time frame: During hospitalization, approximately 3 days

    Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge

  4. Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)

    Time frame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge

    Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa R Roberts, MD

CONTACT

[email protected]

602-526-4397

Anthony A Sochet, MD

CONTACT

[email protected]

727-487-3711

Sponsors and collaborators

Lead sponsor

Johns Hopkins All Children's Hospital

Other

Registry information

Official study title

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

Acronym: CR-AZI Kids

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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