Study Finds Azithromycin Ineffective for Young Children with Severe Wheezing
New insights into treating severe wheezing episodes in young children have emerged from a recent study conducted by University of Arizona researchers. Despite longstanding assumptions about the role of bacterial infections in wheezing and asthma, the study reveals that the antibiotic azithromycin does not alleviate symptoms in preschool-aged children.
Researchers from the University of Arizona College of Medicine – Tucson led a Phase 3 clinical trial named Azithromycin Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED). The trial involved 840 children, aged 18 to 59 months, across eight pediatric emergency departments in the United States, who were randomly given either azithromycin or a placebo for five days.
Kris Hanning/Office of Research and Partnerships
The effectiveness of the antibiotic was evaluated using the Asthma Flare-up Diary for Young Children (ADYC) score, which assesses symptoms like breathing, coughing, and mood based on parental reports. However, results published in The New England Journal of Medicine and presented at the American Thoracic Society meeting indicated no significant difference between the azithromycin and placebo groups.
Wheezing and asthma remain leading causes of hospitalization for children under five, with about 30,000 admissions annually in the U.S. and 2.2 million emergency visits by children aged two to five. The study found that 521 out of 840 participants harbored potentially harmful bacteria, such as Streptococcus pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae, in their throats.
The trial was halted following an interim analysis that showed no improvement in symptoms with antibiotic use. Lead researcher Dr. Fernando Martinez stated, “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.” Martinez is the director of the U of A Asthma and Airway Disease Research Center.
Martinez highlighted that previous studies did not account for bacterial presence when considering antibiotic use for wheezing. He noted, “We’ve been saying for years that antibiotics should not be used in these acute situations because the wheezing is caused by viruses.” Over 86% of children in the study had respiratory virus infections, including the common cold, with 72.5% infected with a cold virus.
Concerns about antibiotic overuse and potential drug resistance further emphasize the need for revised treatment strategies. Martinez suggested that the presence of bacteria might be due to compromised immune systems rather than a direct cause of wheezing. “The bacteria are taking advantage of the fact that the child has an inappropriate response to the virus,” he explained.
Ongoing research by Martinez and his team aims to deepen understanding of the virus-wheezing relationship in preschoolers. “We want to know why the cold virus causes a runny nose and other symptoms in most children,” he said, “but in this group the virus appears to contribute to wheezing and hospitalization.”
Dr. Kurt R. Denninghoff from the Department of Emergency Medicine at the U of A College of Medicine – Tucson also contributed as a co-author. The study received funding from the National Heart, Lung, and Blood Institute and support from the Pediatric Emergency Care Applied Research Network (PECARN), under the Maternal and Child Health Bureau in the Health Resources and Services Administration.
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