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Azithromycin Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)
Study ID: STU-2023-0897
Summary
AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. We will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12mg/kg/day for 5 days) or placebo. We will make separate comparisons in children in whom specific pathogenic bacteria are isolated from nasopharyngeal swabs, and in those in whom they are not isolated. The primary outcome will be the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families will be contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children will participate in two follow-up visits 5x8 days and 14x21 days after visit 1 to assess development of resistance to study drug and treatment response related changes in the airway microbiome.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- MOHAMED KARIM BADAWY
NIH-NATIONAL HEART, LUNG AND BLOOD INST
Lung/Thoracic
To evaluate whether a 5-day course of AZ can decrease, compared to placebo, the severity of the illness, in children 18 to<60 months of age presenting to the ED for severe wheezing and in whom baseline nasopharyngeal samples are positive for H influenzae, M catarrhalis, or S pneumonia. To evaluate whether a 5-day course of AZ can decrease,compared to placebo, the severity of the illness, in children 18 to<60 months of age presenting to the ED for severe wheezing and in whom baseline To assess whether specific nasopharyngeal microbial communities and variants in the genes encoding for CDHR3, IL-8 and in the 17q asthma-related gene cluster predict severity of wheezing episodes and response to AZ in children nasopharyngeal samples test negative for H influenzae, M catarrhalis, and S pneumonia.