Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Location status: Recruiting
NCT Number: NCT06223828
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
Interested in participating?
Request Info3 year–17 year
All sexes
Interventional
Phase 2 / Phase 3
St. Petersburg, Florida, 33701, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10mg/kg/dose (max dose 500mg) once daily for 3 days
Other names: Zithromax
Time frame: 24 hours, 48 hours, and 72-hours following enrollment
ng/dL
Time frame: During hospitalization, approximately 3 days
cumulative incidence rate
Time frame: During hospitalization, approximately 3 days
Measured in Days, from Hospitalization in ICU through Discharge from ICU
Time frame: During hospitalization, approximately 3 days
Measured in Hours from ICU hospitalization through discharge
Time frame: During hospitalization, approximately 3 days
Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge
Time frame: Enrollment, Day 1, Day 2, Day 3, at ICU Discharge
Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit
Contact information is provided by the study sponsor or research team.
Alexa R Roberts, MD
CONTACT
Anthony A Sochet, MD
CONTACT
Johns Hopkins All Children's Hospital
Other
Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
Acronym: CR-AZI Kids
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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