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Macrolide Antibiotic
Zithromax, 100 mgmgs; 5mls suspension for Asthma
N/A
Waitlist Available
Led By David W Johnson, MD
Research Sponsored by Janielee Williamson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
12-60 months
wheeze on auscultation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
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.
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
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Zithromax, 100 mgmgs; 5mls suspensionActive Control1 Intervention
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)
Group II: Suspension placebo,Placebo Group1 Intervention
placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.
Find a Location
Who is running the clinical trial?
Janielee WilliamsonLead Sponsor
University of AlbertaOTHER
884 Previous Clinical Trials
392,620 Total Patients Enrolled
12 Trials studying Asthma
1,448 Patients Enrolled for Asthma
David W Johnson, MDPrincipal InvestigatorAlberta children's Hospital/University of Calgary
1 Previous Clinical Trials
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