NCT01008761

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

November 4, 2009

Last Update Submit

July 11, 2012

Conditions

Asthma

Keywords

Pre-school childWheezy episode

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Zithromax, 100 mgmgs; 5mls suspension

ACTIVE COMPARATOR

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)

Drug: Azithromycin

Suspension placebo,

PLACEBO COMPARATOR

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

Drug: Suspension Placebo

Interventions

AzithromycinDRUG

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)

Also known as: Azithromycin, zithromax, macrolide
Zithromax, 100 mgmgs; 5mls suspension
Suspension PlaceboDRUG

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

Also known as: Azithromycin
Suspension placebo,

Eligibility Criteria

Age12 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months
  • wheeze on auscultation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, T6G 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

AzithromycinMacrolides

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinPolyketidesLactonesOrganic ChemicalsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • David W Johnson, MD

    Alberta children's Hospital/University of Calgary

    PRINCIPAL INVESTIGATOR

  • Piush Mandhane, MD

    Stollery Children's Hospital Edmonton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janielee Williamson, RN

CONTACT

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

David W. Johnson, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CCCRP Research Coordinator

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 6, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

CA(2)