Asthma
Conditions
Keywords
Pre-school child, Wheezy episode
Brief summary
To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.
Interventions
DRUGAzithromycin
Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)
DRUGSuspension Placebo
Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg
Sponsors
University of Alberta
Janielee Williamson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
* 12-60 months * wheeze on auscultation
Exclusion criteria
* antibiotic use in the past 30 days * macrolide allergy * underlying medical condition * significant co-morbidities * current enrollment * language barrier or no access to phone for follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months |
| Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo. | Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months |
Countries
Canada
Contacts
Primary ContactJanielee Williamson, RN
Backup ContactDavid W. Johnson, MD
Outcome results
None listed