Azithromycin to Prevent Bronchopulmonary Dysplasia in Ureaplasma-Infected Preterms

Ureaplasma (UU) respiratory tract colonization is a risk factor for BPD in preterm infants. We hypothesized that azithromycin (AZM) therapy will prevent BPD in UU-colonized preterms. We conducted a Phase IIb RCT of 20 mg/kg x3d IV AZM in infants 24^0-28^6 wks GA randomly assigned within 4d following birth. The primary efficacy outcome was UU-free survival. Secondary outcomes included mortality, UU clearance, physiologic BPD at 36 wks PMA, and 2 yr corrected age serious respiratory morbidity (SRM) and neurodevelopmental impairment (NDI). 121 randomized infants (AZM, N=60; placebo, N=61) were enrolled. 44(36%) were UU+ (AZM, N=19; placebo, N=25). UU-free survival was 55/60 [92%(95%CI, 82%-97%)] for AZM compared to 37/61 [61%(95%CI, 48%-73%)] for placebo. AZM eradicated UU in all UU+AZM infants, but 21/25(84%) UU+placebo infants remained culture+. There were no significant differences in death/SRM (34.8% vs 30.4%, p=0.67) or death/moderate-severe NDI (47% vs 33%, p=0.11) between AZM and placebo groups at 2 yrs.