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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00410054 | Other Identifier | Johns Hopkins University |
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The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin Intervention | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 10mg/kg/dose (max dose 500mg) once daily for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint | ng/dL | 24 hours, 48 hours, and 72-hours following enrollment |
| Drug-related adverse event rate (Primary Safety Endpoint) | cumulative incidence rate | During hospitalization, approximately 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (Secondary Clinical Efficacy Endpoint) | Measured in Days, from Hospitalization in ICU through Discharge from ICU | During hospitalization, approximately 3 days |
| Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint) |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony A Sochet, MD | Contact | 727-487-3711 | Sochet@jhmi.edu | |
| Alexa R Roberts, MD | Contact | 602-526-4397 | arober77@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anthony A Sochet, MD | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins All Children's Hospital | Recruiting | St. Petersburg | Florida | 33701 | United States |
No plan to share with other researchers.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Children will be enrolled into either a single interventional arm or a parallel standard care arm.
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Measured in Hours from ICU hospitalization through discharge
| 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 | 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 | Enrollment, Day 1, Day 2, Day 3, at ICU Discharge |
| Organic Chemicals |