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Macrolide Antibiotic

Azithromycin Intervention for Asthma (CR-AZI Kids Trial)

Phase 2 & 3

Recruiting

Led By Anthony A Sochet, MD

Research Sponsored by Johns Hopkins All Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admission to the PICU

Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours, 48 hours, and 72-hours following enrollment

Awards & highlights

CR-AZI Kids Trial Summary

This trial will examine how Azithromycin affects the immune system in children with severe asthma.

Who is the study for?

This trial is for children aged 3-17 who are in the Pediatric Intensive Care Unit (PICU) with a primary diagnosis of critical asthma. They must be prescribed continuous inhaled or IV beta-agonist therapy and IV systemic corticosteroids to participate.Check my eligibility

What is being tested?

The CR-AZI Study is testing the effects of Azithromycin, an antibiotic that may also help control inflammation, on children with severe asthma to see if it can improve their condition.See study design

What are the potential side effects?

Azithromycin may cause stomach upset, diarrhea, nausea, vomiting or rash. In rare cases, it could lead to more serious side effects like liver problems or hearing issues.

CR-AZI Kids Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been admitted to the Pediatric Intensive Care Unit.

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I am prescribed continuous inhaled or IV beta-agonist therapy.

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I am between 3 and 17 years old.

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I am prescribed IV corticosteroids.

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My condition is diagnosed as severe asthma.

CR-AZI Kids Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours, 48 hours, and 72-hours following enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours, 48 hours, and 72-hours following enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 48 hours, and 72-hours following enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Drug-related adverse event rate (Primary Safety Endpoint)

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

Secondary outcome measures

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

Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)

Length of Stay (Secondary Clinical Efficacy Endpoint)

+1 more

Side effects data

From 2018 Phase 4 trial • 190238 Patients • NCT02047981

Death

100%

80%

60%

40%

20%

Study treatment Arm

Biannual Mass Oral Placebo

Biannual Mass Oral Azithromycin

CR-AZI Kids Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Azithromycin InterventionExperimental Treatment1 Intervention

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

Group II: Standard CareActive Control1 Intervention

Participants will receive standard care without Azithromycin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018

Completed Phase 4

~274950

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins All Children's HospitalLead Sponsor

43 Previous Clinical Trials

5,007,439 Total Patients Enrolled

1 Trials studying Asthma

92 Patients Enrolled for Asthma

Anthony A Sochet, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research study?

"Participants aged between 3 and 17 with a confirmed diagnosis of asthma are eligible to enroll in this study. The aim is to recruit a total of 100 participants."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The primary focus of this clinical investigation, to be assessed at 24 hours, 48 hours, and 72 hours post-enrollment period, is the rate of drug-related adverse events (Primary Safety Endpoint). Secondary endpoints include Length of Stay (Secondary Clinical Efficacy Endpoint), measured in days from ICU admission to discharge; Composite use of additional asthma treatments (Secondary Clinical Efficacy Endpoint), quantified as cumulative frequency throughout the patient's stay in the ICU; and Transcutaneous carbon dioxide levels (Secondary physiologic efficacy endpoint), expressed as peak values daily during each assessment visit."

Answered by AI

Are there any ongoing efforts to enroll participants for this study at the moment?

"As per the data available on clinicaltrials.gov, this research is in an active phase of participant recruitment. The trial was first made public on April 2nd, 2024 and underwent its most recent update on April 18th, 2024."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, data on clinicaltrials.gov reveals that this study is actively seeking subjects. The trial was initially listed on 4/2/2024 and last modified on 4/18/2024. It aims to recruit a total of 100 participants from one designated site."

Answered by AI