Azithromycin fails to Improve Outcomes in Preterm Infants at Risk of chronic lung disease of prematurity: Lancet

Chronic lung disease of prematurity (CLD), a major health concern in preterm infants, can lead to significant morbidity and mortality. There has been conflicting evidence on whether macrolide antibiotics like azithromycin could potentially reduce the rates of CLD in at-risk infants, particularly those colonized with pulmonary Ureaplasma spp..

The AZTEC trial was conducted across 28 neonatal intensive care units in the UK. The study included infants born at less than 30 weeks' gestation who had received non-invasive or invasive respiratory support within 72 hours of birth. Infants were randomly allocated to either receive intravenous azithromycin or a placebo, with masking to ensure blinding. The primary outcome assessed was survival without moderate or severe CLD at 36 weeks’ postmenstrual age.

The key findings of the study were as follows:

• Survival without moderate or severe CLD occurred in 42% of infants in the azithromycin group and 45% in the placebo group (aOR 0.84, 95% CI 0.55–1.29, p=0.43).

• Seven serious adverse events were reported in the azithromycin group (5 severe, 2 moderate), while 6 occurred in the placebo group (2 severe, 2 moderate, 2 mild).

• The researchers concluded that the use of azithromycin did not significantly improve survival without CLD, regardless of the presence of pulmonary Ureaplasma spp. colonization.

Given the lack of efficacy in improving outcomes, azithromycin should not be recommended for preventing CLD in preterm infants at risk. These findings have important implications for clinical practice, highlighting the need for alternative approaches in managing and preventing CLD in this vulnerable population.

The AZTEC trial provides clear evidence that prophylactic azithromycin is not beneficial for preterm infants at risk of chronic lung disease of prematurity. Clinicians should consider other strategies for managing this condition in infants born at less than 30 weeks' gestation.

Reference:

Lowe, J., Gillespie, D., Aboklaish, A., Lau, T. M. M., Consoli, C., Babu, M., Goddard, M., Hood, K., Klein, N., Thomas-Jones, E., Turner, M., Hubbard, M., Marchesi, J., Berrington, J., & Kotecha, S. (2024). Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet. Respiratory Medicine. https://doi.org/10.1016/s2213-2600(24)00079-1