Pediatric AsthmaPhase 2/3CR-AZI KidsNCT06223828
Azithromycin for Critical Asthma - Pediatrics
A Phase 2/3 study testing Azithromycin in people with Pediatric Asthma and Critical Illness, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Pediatric Asthma, Critical Illness
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 30 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Anthony A Sochet, MD, 727-767-2912, sochet@jhmi.edu
About this study
Official title: Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Read the detailed description
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
- Pediatric Asthma, Critical Illness
- Being tested
- Azithromycin
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
10mg/kg/dose (max dose 500mg) once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Intervention | Experimental | Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days. Receives: Drug: Azithromycin |
| Standard Care | No intervention | Participants will receive standard care without Azithromycin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
ng/dL
Measured: 24 hours, 48 hours, and 72-hours following enrollment
Drug-related adverse event rate (Primary Safety Endpoint)
cumulative incidence rate
Measured: During hospitalization, approximately 3 days
Secondary outcomes (4)
Length of Stay (Secondary Clinical Efficacy Endpoint)
Measured in Days, from Hospitalization in ICU through Discharge from ICU
Measured: During hospitalization, approximately 3 days
Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)
Measured in Hours from ICU hospitalization through discharge
Measured: During hospitalization, approximately 3 days
Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)
Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge
Measured: During hospitalization, approximately 3 days
Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)
Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit
Measured: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start2 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Children will be enrolled into either a single interventional arm or a parallel standard care arm.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony A Sochet, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223828
- Sponsor's protocol ID
- CR-AZI
- Other IDs
- IRB00410054
- Acronym
- CR-AZI Kids
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
- ClinicalTrials.gov ID
- NCT06223828
- Acronym / sponsor ID
- CR-AZI Kids / CR-AZI
- Conditions
- Pediatric Asthma, Critical Illness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Children will be enrolled into either a single interventional arm or a parallel standard care arm.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Intervention | Experimental | Drug: AzithromycinParticipants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days. |
| Standard Care | No intervention | –Participants will receive standard care without Azithromycin. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: Zithromax10mg/kg/dose (max dose 500mg) once daily for 3 days | Drug | Azithromycin Intervention |
Primary outcome
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
Drug-related adverse event rate (Primary Safety Endpoint)
Time frame: During hospitalization, approximately 3 days
cumulative incidence rate
4 secondary outcomes
Length of Stay (Secondary Clinical Efficacy Endpoint)
Time frame: During hospitalization, approximately 3 days
Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)
Time frame: During hospitalization, approximately 3 days
Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)
Time frame: During hospitalization, approximately 3 days
Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)
Time frame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. No plan to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony A Sochet, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azithromycin in people with Pediatric Asthma and Critical Illness, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony A Sochet, MD (727-487-3711, Sochet@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.