Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial

Bacterial sepsis remains a leading cause of death among neonates with Staphylococcus aureus, Group B Streptococcus (GBS) and Streptococcus pneumoniae identified as the most common causative pathogens in Africa. Asymptomatic bacterial colonization is an intermediate step towards sepsis. We conducted a phase-III, double-blind, placebo-controlled randomized trial to determine the impact of giving one oral dose of azithromycin to Gambian women in labour on the nasopharyngeal carriage of S. aureus, GBS or S. pneumoniae in the newborn at day 6 post-partum. Study participants were recruited in a health facility in Western Gambia. They were followed during 8 weeks and samples were collected during the first 4 weeks. Between April 2013-2014, we recruited 829 women who delivered 843 babies, including 13 stillbirths. Sixteen babies died during the follow-up period. No maternal deaths were observed. No serious adverse events related to the intervention were reported. According to the intention-to-treat analysis, prevalence of nasopharyngeal carriage of the bacteria of interest in the newborns at day 6 was lower in the intervention arm [65.1% versus 28.3% - Prevalence Ratio (PR)=0.43; 95%CI: 0.36-0.52, p