• Anna Roca, Bully Camara, Joel D Bognini, Usman N Nakakana, Athasana M Somé, Nathalie Beloum, Toussaint Rouamba, Fatoumata Sillah, Madikoi Danso, Joquina C Jones, Shashu Graves, Isatou Jagne, Pauline Getanda, Saffiatou Darboe, Marc C Tahita, Ebrahim Ndure, Hien S Franck, Sawadogo Y Edmond, Bai L Dondeh, Wilfried G J Nassa, Zakaria Garba, Abdoulie Bojang, Yusupha Njie, Christian Bottomley, Halidou Tinto, Umberto D'Alessandro, and PregnAnZI-2 Working Group.
• MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
• JAMA. 2023 Mar 7; 329 (9): 716724716-724.

ImportanceNeonatal sepsis is a leading cause of neonatal mortality. New interventions are needed to decrease neonatal sepsis and mortality in regions with highest burden.ObjectiveTo evaluate the efficacy of intrapartum azithromycin to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections.Design, Setting, And ParticipantsThis double-blind, placebo-controlled, randomized clinical trial enrolled and followed up birthing parents and their infants at 10 health facilities in The Gambia and Burkina Faso, West Africa, between October 2017 and May 2021.InterventionsParticipants were assigned at random to receive oral azithromycin (2 g) or placebo (ratio 1:1) during labor.Main Outcomes And MeasuresThe primary outcome was a composite of neonatal sepsis or mortality, with the former defined based on microbiologic or clinical criteria. Secondary outcomes were neonatal infections (skin, umbilical, eye and ear infections), malaria, and fever; postpartum infections (puerperal sepsis, mastitis), fever, and malaria; and use of antibiotics during 4-week follow-up.ResultsThe trial randomized 11 983 persons in labor (median age, 29.9 years). Overall, 225 newborns (1.9% of 11 783 live births) met the primary end point. The incidence of neonatal mortality or sepsis was similar in the azithromycin and placebo groups (2.0% [115/5889] vs 1.9% [110/5894]; risk difference [RD], 0.09 [95% CI, -0.39 to 0.57]), as was the incidence of neonatal mortality (0.8% vs 0.8%; RD, 0.04 [95% CI, -0.27 to 0.35]) and neonatal sepsis (1.3% vs 1.3%; RD, 0.02 [95% CI, -0.38 to 0.43]). Newborns in the azithromycin group compared with the placebo group had lower incidence of skin infections (0.8% vs 1.7%; RD, -0.90 [95% CI, -1.30 to -0.49]) and need for antibiotics (6.2% vs 7.8%; RD, -1.58 [95% CI, -2.49 to -0.67]). Postpartum parents in the azithromycin group had lower incidence of mastitis (0.3% vs 0.5%; RD, -0.24 [95% CI, -0.47 to -0.01]) and puerperal fever (0.1% vs 0.3%; RD, -0.19 [95% CI, -0.36 to -0.01]).Conclusions And RelevanceAzithromycin administered orally during labor did not reduce neonatal sepsis or mortality. These results do not support routine introduction of oral intrapartum azithromycin for this purpose.Trial RegistrationClinicalTrials.gov Identifier: NCT03199547.

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