Prevention of Bacterial Infections in Newborn
Condition: Neonatal Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The last decade has witnessed an important reduction of the mortality in children under 5
      years but such reduction has not impacted in neonates. Mortality in neonates contributes 40%
      of all deaths occurring in children below 5 years of age.

      Severe bacterial disease is among the leading causes of neonatal deaths. Bacterial 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 in
      all age groups, with the consequence that 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 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.

      The purpose of this trial is to evaluate the impact of a single oral dose of azithromycin
      given to women in labour on bacterial carriage of the newborn as well as the women during the
      first month after delivery.

      The investigators 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 many of the bacteria commonly causing
      severe disease in newborn.

      This clinical trial will be conducted in a peri-urban health facility in Western Gambia. 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 (most African women deliver at home
      assisted by traditional birth assistants), decreases the occurrence of neonatal bacterial
      disease
    


Intervention name(s): Azithromycin and Placebo
Intervention type(s): Drug
Intervention description(s): A single oral dose of 2g of Azithromycin will be given to the women in labour
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prevention; bacterial infection; neonates; women in labour; Azithromycin