Table 4.

Summary of Study With Long-Term Outcomes as the Primary Objective¹⁶

Reference	Design	Population	Azithromycin Dose and Duration	Results
Viscardi16	Prospective, placebo-controlled (AZM, n = 60; placebo, n = 61)	AZM: GA: 26.2 ± 1.4 wk BW: 895 ± 215 g CA: 23.7 ± 2.1 mo (n = 48) Placebo: GA: 26.2 ± 1.4 wk BW: 903 ± 245 g CA: 23.7 ± 2.1 mo (n = 46)	20 mg/kg IV every 24 hr × 3 days	Rate of Ureaplasma positive: 35.5% of patients were Ureaplasma positive Incidence of death or serious respiratory morbidity at 22–26 mo CA: No difference between AZM and placebo group (34.8% versus 30.5%; p = 0.67) In Ureaplasma-positive patients (n = 44), increased rate in AZM versus placebo patients (52.6% versus 28.8%; p = 0.064) In Ureaplasma-positive patients (n = 44), greater serious respiratory morbidity in AZM versus placebo group (44.3% versus 15.2%; p = 0.036) Other outcomes at 22–26 mo CA: No difference in albuterol, diuretics, inhaled corticosteroids, or oral prednisone between groups No difference in parenteral report of chronic wheezing or cough between groups No difference in need for hospitalization between groups ADE: No ADE with AZM observed Developmental outcomes: No difference in death or moderate-to-severe NDI in AZM versus placebo group (47.2% versus 32.7%; p = 0.11) No difference BSID-III scores, ASQ-3 scores, or diagnosis of cerebral palsy between groups

ADE, adverse drug event; ASQ-3, Ages and Stages Questionnaire, third edition; AZM, azithromycin; BSID-III, Bayley Scales of Infant and Toddler Development, third edition; BW, birth weight; CA, corrected age; GA, gestational age; IV, intravenous; NDI, neurodevelopmental impairment