Recruiting

Azithromycin

Sponsor:

Janielee Williamson

Code:

NCT01008761

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

Interventions

Azithromycin

Suspension Placebo

Study Details

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.

Conditions

Asthma

Study ID

NCT01008761

Start date

Jan, 2010

Status verified date

Jul, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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)

placebo comparator: Suspension placebo,

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

Interventions

Azithromycin

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)

Suspension Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Janielee Williamson, RN

403-955-3186janie.williamson@albertahealthservices.ca

David W. Johnson, MD

403-955-7507david.johnson@alberthealthservices.ca

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Janielee Williamson, RN

403-955-3186janie.williamson@albertahealthservices.ca

Paula Finnson

403-955-7873paula.finnson@albertahealthservices.ca

Principal Investigator:

David Johnson, MD

Stollery Children's Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2V7

Contacts

Piush Mandhane, MD

piush.mandhane@albertahealthservices.ca

Principal Investigator:

Piush Mandhane, MD

More Information

Sponsor

Janielee Williamson

Last update posted

Jul 12, 2012

Last verified

Jul, 2012

Keywords

  • Pre-school child
  • Wheezy episode

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Janielee Williamson on 2012-07-12.