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What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinAzithromycin 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)

Drug:Suspension PlaceboPlacebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Zithromax, 100 mgmgs; 5mls suspensionAzithromycin 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)

Suspension placebo,placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.

Study Status

Unknown status

Start Date: January 2010

Completed Date: December 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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: 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

Study sponsors, principal investigator, and references

Principal Investigator: David W Johnson, MD

Lead Sponsor: Janielee Williamson

Collaborator: University of Alberta

More information:https://clinicaltrials.gov/show/NCT01008761