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Official websites use. Share sensitive information only on official, secure websites. Correspondence to Dr Maeve Hume-Nixon; maeve. Infections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally.
Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections SSTIs than high-income countries. Research from the Gambia found that a single dose of oral azithromycin in labour decreased bacterial carriage and infections in mothers and infants, particularly infant skin infections.
The Bulabula MaPei clinical trial evaluates the safety and efficacy of a single dose of azithromycin in labour in reducing the incidence of maternal and infant SSTIs and other infections and the impact on bacterial carriage. It will also describe the effect of azithromycin on antimicrobial AMR resistance, the maternal and infant microbiome, and infant dysbiosis.
Secondary outcomes include the incidence of other infant and maternal infections, and safety and tolerability of azithromycin in mother and infant.
Following informed consent, pregnant women will be randomised in a ratio, with all study staff and participants masked to group allocation. Recruitment for Bulabula MaPei started in June The findings of this study will be disseminated in peer-reviewed journals and presented at conferences. The benefits and potential harms of azithromycin on common bacterial pathogens will be determined by comparing carriage, antimicrobial resistance, and infant and maternal microbiome, including potential sequelae associated with microbiome dysbiosis, between the azithromycin and placebo groups.