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Azithromycin for Critical Asthma - Pediatrics

NCT ID: NCT06223828

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pediatric Asthma Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Children will be enrolled into either a single interventional arm or a parallel standard care arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin Intervention

Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

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

Standard Care

Participants will receive standard care without Azithromycin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Azithromycin

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

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins All Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony A Sochet, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

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Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anthony A Sochet, MD

Role: CONTACT

[email protected]
727-487-3711

Alexa R Roberts, MD

Role: CONTACT

[email protected]
602-526-4397

Facility Contacts

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Anthony A Sochet, MD

Role: primary

[email protected]
727-767-2912

Other Identifiers

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CR-AZI

Identifier Type: -

Identifier Source: org_study_id

IRB00410054

Identifier Type: OTHER

Identifier Source: secondary_id