Recruiting
Phase 2
Phase 3

Azithromycin

Sponsor:

Johns Hopkins All Children's Hospital

Code:

NCT06223828

Conditions

Pediatric Asthma

Critical Illness

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Azithromycin

Study Details

Brief summary:

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

Conditions

Pediatric Asthma

Critical Illness

Study ID

NCT06223828

Start date

Apr 2, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Azithromycin Intervention

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

no intervention: Standard Care

Participants will receive standard care without Azithromycin.

Interventions

Azithromycin

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

Primary outcome measure

  • 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 ]
  • Drug-related adverse event rate (Primary Safety Endpoint) [ Time Frame: During hospitalization, approximately 3 days ]

Central Contacts and Locations

Central contacts

Anthony A Sochet, MD

727-487-3711Sochet@jhmi.edu

Alexa R Roberts, MD

602-526-4397arober77@jhmi.edu

Locations

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Anthony A Sochet, MD

727-767-2912sochet@jhmi.edu

More Information

Sponsor

Johns Hopkins All Children's Hospital

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins All Children's Hospital on 2026-08-11.