A randomized control trial of azithromycin for the acute management of wheezy pre-school children

• Author / Creator

  Silbernagel, Patricia del Rocio

• Objective: We sought to determine if azithromycin, a macrolide antibiotic with anti-inflammatory(1,2), antibacterial(3) and potential antiviral(4) properties, added to routine therapy of wheezy pre-school children would resolve respiratory symptoms more rapidly, and protect against symptom reoccurrence longer than the addition of placebo. Study design: We completed a double blind, randomized, placebo-control trial in which pre-school children were randomized to receive five days of azithromycin or placebo in addition to their regular treatment in the emergency department. The primary outcome was time to resolution of symptoms during the following 21 days after enrolment. Secondary outcomes included the number of days children used a short-acting beta-agonist during the 21 days following randomization and the time to reoccurrence during the following six months of follow-up. Result: A total of the 300 wheezing children were randomized, 222 had sufficient data to be included in primary outcome analysis and 169 were analyzed for secondary outcomes. The treatment groups had similar demographics and clinical parameters at baseline. Median time to resolution of respiratory symptoms was four days for both treatment arms (interquartile range (IQR) 3,6; p=0.28). Median number of days of Short-Acting Beta-Agonist use among those who received azithromycin was four and a half days (IQR 2, 7) and five days (IQR 2, 9; p=0.22) among those who received placebo. Participants who received azithromycin had a 0.91 hazard ratio for time to six-month exacerbation compared to placebo (95% CI 0.61, 1.36, p=0.65). A pre-determined subgroup analysis showed no differences in outcomes for children with their first or repeat episode of wheezing. There was no significant difference in the proportion of participants experiencing an adverse event. Conclusion: Azithromycin did not reduce the duration of respiratory symptoms nor the time to a respiratory exacerbation in the following six months after treatment among wheezing preschool children presenting to an emergency department. There was no significant effect among either first-time or prior wheezing children.

• Subjects / Keywords

  • Pediatric
  • Randomized controlled trial
  • Azithromycin
  • Wheezing
  • Wheeze

• Graduation date

  Fall 2017

• Type of Item

  Thesis

• Degree

  Master of Science

• DOI

  https://doi.org/10.7939/R3SX64S2H

• License

  This thesis is made available by the University of Alberta Libraries with permission of the copyright owner solely for non-commercial purposes. This thesis, or any portion thereof, may not otherwise be copied or reproduced without the written consent of the copyright owner, except to the extent permitted by Canadian copyright law.