A randomized Phase 3 trial tested whether azithromycin improves wheezing in preschool children seen in emergency departments. The study enrolled 840 children aged 18 to 59 months at eight pediatric emergency departments and assigned them to azithromycin or placebo for five days. Outcomes were measured with the Asthma Flare-up Diary for Young Children (ADYC), a daily parent-report tool covering breathing, coughing, appetite, mood and related symptoms. Results were published in The New England Journal of Medicine and presented at the American Thoracic Society meeting in Orlando.
The trial was stopped early after an interim analysis showed no improvement in ADYC scores for children receiving azithromycin compared with placebo. There was also no difference among the children who carried potentially harmful nasopharyngeal bacteria when they arrived at the emergency department.
Many participants carried bacteria and viruses. In total, 521 of the 840 children tested positive for at least one of these bacteria:
- Streptococcus pneumoniae
- Moraxella catarrhalis
- Haemophilus influenzae
Most children had respiratory viruses: slightly more than 86% carried one or more viruses, and 72.5% were infected with a cold virus. Martinez and colleagues suggest that bacteria may colonize children who are already susceptible to viral damage, rather than causing the wheezing. Martinez said, “We can say with a high degree of certainty that children who come to the doctor’s office or the emergency room with a severe wheezing episode should not be given azithromycin or any antibiotic.” The study highlights concerns about antibiotic overuse, drug resistance and potential effects on immune development. The research was funded in part by the National Heart, Lung, and Blood Institute and supported by PECARN, with backing from the Maternal and Child Health Bureau in the Health Resources and Services Administration under the EMSC program.
Difficult words
- randomize — assign people to different groups by chancerandomized
- placebo — a fake treatment given to compare effects
- interim analysis — a planned review of data before trial ends
- nasopharyngeal — relating to the nose and upper throat area
- colonize — settle and grow on a body surface
- susceptible — likely to be harmed or affected by something
- antibiotic overuse — using antibiotics more than medically necessary
- drug resistance — when medicines stop working against germs
- immune development — process of the body's defense system maturing
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- What are the possible harms of antibiotic overuse mentioned in the article, and why do they matter for children?
- Given that most children had respiratory viruses, how might this affect doctors' choices when treating preschool wheezing?
- Do you think stopping a trial early is justified when interim results show no benefit? Explain your reasons using the study details.
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