Prevention of bacterial infections in the newborn by pre-delivery administration of azithromycin

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The last decade has witnessed an important reduction of the mortality in children less than 5 years of age. Nevertheless, such reduction occurred mainly in children older than 1 month; no change was observed in newborns (between birth and one month of age). Mortality in this age group contributes half of all deaths occurring in children below 5 years of age. Sixteen out of the 20 countries with the highest neonatal mortality are in sub-Saharan Africa. In 1990, the United Nations established the Millennium Development Goals (MDG) aiming at improving by 2015 living conditions of the poorest populations. The MDG number 4 aims at reducing by two-thirds the under-five mortality, a result attainable only with a substantial reduction in neonatal deaths.Severe bacterial disease is among the leading causes of neonatal deaths. In Sub-Saharan Africa, different bacteria are responsible for these deaths during the first month of life. Severe neonatal disease follows bacterial infection. Individuals can be infected without developing disease (carriage stage) but infection is needed to subsequently develop disease. In Sub-Saharan Africa, bacterial carriage (i.e. in the birth canal and/or nasopharyngeal tract) is very common, with the consequence that the occurrence of bacterial disease is one of the highest in the world. Newborns can be infected during labour - when passing through the birth canal - and also during the first days/weeks of life, as a consequence of the close physical contact with the mother, if the latter carries bacteria in the nasopharyngeal tract. If the mother is an important source of bacterial infection to the newborn, treating mothers with a powerful antibiotic during labour should decrease bacterial carriage and therefore diminish the risk of bacterial transmission to the newborn during the first days/weeks of life, which should in turn result in the lower occurrence of severe bacterial disease and hence lower mortality. In the study proposed, we will determine whether a single antibiotic dose given to the mother during labour decreases the bacterial carriage of the newborn during the first month of life.We have selected an antibiotic (azithromycin) that in Sub-Saharan Africa has already shown both a strong impact on bacterial nasopharyngeal carriage and on all-cause mortality when administered to everybody in a community (mass drug administration). This specific antibiotic has several advantages for being deployable as a simple intervention in rural Africa, i.e. it requires a single oral administration, it has no special storage requirements and it has the potential to eliminate most of the bacteria commonly causing severe disease in newborn. A clinical trial will be conducted in a rural health facility in Western Gambia to evaluate the effect of treating mothers during labour on bacterial infection in the newborn during the first weeks of life. If an impact is shown, the next step would be to conduct a larger study aiming at establishing if the intervention, implemented at a lower level of care (as most African women deliver at home assisted by traditional birth assistants), decreases the occurrence of neonatal invasive bacterial disease.