Early Administration of Azithromycin May Reduce Risk of Severe Lower Respiratory Tract Illness in Children

Wednesday, November 18, 2015

CINCINNATI – Early use of an antibiotic significantly reduces the risk of severe lower respiratory tract illness (LRTI) in young children with a history of recurrent episodes of the condition, according to a study published Nov. 17 in JAMA.

“The study shows that, compared to placebo, early use of the antibiotic azithromycin during an apparent respiratory tract illness can help prevent the progression to an LRTI in children known to have recurrent bouts with this illness,” said Theresa Guilbert, MD, MS, study co-author and co-director of the Asthma Center at Cincinnati Children’s Hospital Medical Center. “Identifying treatment approaches that lessen the severity of these recurrent episodes would provide substantial benefit to preschool children prone to recurrent and severe LRTI.”

Acute episodes of severe LRTI are common among preschoolers, and 14 percent to 26 percent of preschoolers experience recurrent wheezing during the first 6 years of life, according to study authors. These severe episodes are often associated with substantial illness, and may result in visits to urgent care and emergency departments. Although viral infections are often present, bacteria may also contribute to illness development, according to the authors.

Guilbert and her research colleagues randomly assigned 607 children (age 12 months through 71 months) with histories of recurrent, severe LRTIs to receive either the antibiotic azithromycin or a matching placebo for five days (307 received the drug, 300 received placebo). Based on individualized action plans, administration of the drug or placebo started early during each predefined respiratory track illness (a child's signs or symptoms prior to development of LRTI). The trial was conducted across nine academic U.S. medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network. 

Among the study participates there were a total of 937 treated respiratory tract illnesses (473 RTIs in the azithromycin group, 464 in the placebo group). Those RTIs affected 223 children in the group receiving the drug and 220 children receiving placebo. In the group that received the drug, there were 35 severe LRTIs, compared to 57 LRTIs in the children who received placebo. Researchers said this shows the azithromycin group experienced a significantly lower risk of progressing to severe LRTI than the placebo group. Adverse events observed by the research team were infrequent.  

The researchers did note that they found significant rates of azithromycin-resistant organisms in the throat samples of both children who received the drug and those who did not. Because of the current study’s relatively small sample size, the authors recommended additional studies to assess the potential risk of antibiotic resistance and the comparative effectiveness of azithromycin in preventing LRTI when tested against other medications.

The authors went on to write: “In children with the phenotype of wheezing studied herein, clinicians may consider a therapeutic trial of azithromycin early in the course of RTIs based on a parent-initiated individualized plan. Children who demonstrate an azithromycin response, as reflected by less-severe episodes of RTI, may benefit from repeating such therapy with subsequent illnesses.”

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Cincinnati Children’s Hospital Medical Center ranks third in the nation among all Honor Roll hospitals in U.S. News & World Report’s 2015 Best Children’s Hospitals. It is also ranked in the top 10 for all 10 pediatric specialties. Cincinnati Children’s, a non-profit organization, is one of the top three recipients of pediatric research grants from the National Institutes of Health, and a research and teaching affiliate of the University of Cincinnati College of Medicine. The medical center is internationally recognized for improving child health and transforming delivery of care through fully integrated, globally recognized research, education and innovation. Additional information can be found at Connect on the Cincinnati Children’s blog, via Facebook and on Twitter.

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Nick Miller, 513-803-6035,