A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 440
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Months to 60 Months (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Zithromax, 100 mgmgs; 5mls suspension
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)
Intervention: Azithromycin (Drug)
Suspension placebo,
placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.
Intervention: Suspension Placebo (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)
- 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)
Investigators
Janielee Williamson
CCCRP Research Coordinator
Alberta Children's Hospital