New research conducted by Cardiff University has reported that early prophylactic use of azithromycin does not offer significant benefits in preventing chronic lung disease in premature babies. The study was published in the journal of The Lancet Respiratory Medicine. Chronic lung disease, also known as bronchopulmonary dysplasia, poses a significant health risk to prematurely born infants, often leading to mortality and long-term morbidity such as the premature onset of chronic obstructive lung disease.
Dr. Lowe and colleagues highlighted that despite improvements in neonatal care, the incidence of chronic lung disease among premature babies has not decreased. This medical condition mainly affects newborns that are born prematurely, usually <30 weeks of gestation. The efficacy of macrolide antibiotics, including azithromycin, in reducing the incidence of chronic lung disease in premature infants has been a subject of debate for decades. Previous smaller-scale trials have yielded conflicting results, prompting the need for further investigation to corroborate the role of azithromycin.
This multicenter, double-blind, randomized, and placebo-controlled trial titled ‘AZTEC’ was conducted in 28 neonatal intensive care units in the UK. The study recruited 796 premature babies and aimed to determine whether azithromycin administration could reduce the rates of chronic lung disease in this vulnerable population. Infants were eligible to participate in the trial and were randomly assigned to receive either intravenous azithromycin at a dose of 20 mg/kg per day for three days, followed by 10 mg/kg for seven days, or a placebo. The allocation was stratified by the center and gestational age at birth, with a 1:1 ratio using random permuted blocks of four.
The results of the study indicated that a singular intervention with azithromycin did not yield the desired reduction in chronic lung disease among premature babies. This finding underscores the complexity of treating this condition and suggests that a multifaceted approach may be necessary to address it effectively. Survival without moderate or severe chronic lung disease was observed in 42% of infants in the intervention group and 45% in the placebo group. The adjusted odds ratio (aOR) for this outcome was 0.84 (95% CI 0.55–1.29, p=0.43), indicating no significant difference between the two groups. The presence of pulmonary Ureaplasma spp colonization did not affect the treatment’s efficacy.
Regarding safety, seven serious adverse events were reported in the azithromycin group, with five classified as severe and two as moderate. In comparison, the placebo group reported six serious adverse events, including two severe, two moderate, and two mild cases, according to assessments by the local principal investigators.
The researchers highlighted the importance of assessing the longer-term effects of azithromycin on both respiratory and neurodevelopmental outcomes in premature infants. Understanding the extended efficacy and safety profile of the antibiotic is crucial in guiding clinical decision-making, particularly in light of the global challenge of antibiotic resistance.
Moreover, the study’s findings carry implications for antibiotic stewardship efforts, emphasizing the need to judiciously evaluate the use of antibiotics in neonatal care settings. Given the emergence of antibiotic resistance as a pressing public health concern, it is imperative to avoid unnecessary antibiotic administration whenever possible.
The research outcomes have significant implications for clinical practice, providing clarity on the effectiveness of azithromycin in preventing chronic lung disease in premature infants. By ruling out azithromycin as a viable intervention for this condition, healthcare providers can better tailor treatment strategies and avoid the inappropriate use of antibiotics.
Reference
Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trial – The Lancet Respiratory Medicine [Internet]. [cited 2024 Apr 29].