Preschool children presenting to emergency departments for wheezing did not benefit from the addition of azithromycin to symptomatic treatment.
Preschool children presenting to emergency departments for wheezing did not benefit from add-on azithromycin treatment, in a study comparing their course to children receiving placebo addition to symptomatic treatment.
The results contrasted with findings of 2 other trials of azithromycin in children cited by the investigators, as well as a study in adults recently reported in MD Magazine. Lead author Piushkumar Mandhane, MD, of the Department of Pediatrics in the Faculty of Medicine and Dentistry at the University of Alberta, in Edmonton, commented on the differences.
"I think our study highlights the need to really identify the patients who you think may respond to azithromycin," Mandhane told MD Magazine. "We didn't find an impact of azithromycin when azithromycin was used on all children, while the...studies found an impact of azithromycin among children at high risk for asthma. The different results really speak to being judicious in your use of azithromycin for wheezing children."
Mandhane and colleagues recruited 300 children between 12 and 60 months of age presenting to emergency departments for wheezing to participate in the double-blinded, placebo-controlled randomized trial. Children were excluded if they had received an antibiotic within the previous 30 days or had a contraindication to macrolide antibiotics.
The antibiotic group received a five-day regimen with 10 mg/kg azithromycin suspension on the first day and 5 mg/kg on days 2-5, while the placebo group received an inactive suspension with identical flavor.
The study design proved challenging, Mandhane acknowledged, with the investigators extending their target completion date by almost 3 years to ensure sufficient enrollment.
"One problem somewhat unique to this study was the number of children who had been on antibiotics in the last 30 days and the number of patients who did not want their child to be on antibiotics unnecessarily," Mandhane said. "I think the former speaks to the high prevalence of antibiotic use in pediatrics--highlighting the importance of further research into the efficacy and effectiveness. While the latter is a positive finding that the public education messaging on judicious antibiotic use is reaching some families."
The study primary outcome was time to resolution of respiratory symptoms after initiating treatment, assessed in 222 of the 300 children. Secondary outcomes, tracked in 169 children, were the number of days children used a short-acting beta-agonist inhalant within 21 days of initial treatment, and time to disease exacerbation during 6 months of follow-up.
Outcomes were quantified from daily calendar diaries, and disease exacerbation was determined from unscheduled healthcare visits or systemic corticosteroids prescribed for acute respiratory symptoms.
The investigators found no apparent benefit from the add-on azithromycin, with 4 days median time to resolution of respiratory symptoms in both groups. The median time to use of a short-acting beta-agonist was 4.5 days in the antibiotic group and 5 days with placebo. There was no statistically significant difference between the groups in periods between initial and repeat episodes of wheezing.
Although there was also no difference in adverse events between groups, Mandhane and colleagues conclude, "we do not recommend azithromycin for the regular management of preschool wheezing children presenting to the emergency department."
The assessment of azithromycin treatment of preschool children with wheezing was published online August 3 in PLOSone.