Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso
Condition: Childhood Mortality
Intervention: Azithromycin; Placebo
Intervention description: a single dose of Azithromycin will be administered to infants between their 8-27th days of life; a single dose of Placebo will be administered to infants between their 8-27th days of life
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: individually randomized trial of azithromycin versus placebo to establish the efficacy and safety of administration of a dose of azithromycin during the neonatal period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21832.0
Sex: All
Minimum age: 8 Days
Maximum age: 27 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: childhood mortality; neonates; azithromycin; mass drug administration

Summary:

      Although under-5 mortality rates are declining globally, neonatal mortality remains
      persistently high in many regions of sub-Saharan Africa. Mass azithromycin distribution to
      children aged 1-59 months has been shown to reduce childhood mortality in Niger, Tanzania,
      and Malawi. This study did not evaluate the effect of azithromycin administered during the
      neonatal period. Observational evidence from high income countries has suggested that
      macrolides, including erythromycin and azithromycin, may be associated with increased risk of
      development of infantile hypertrophic pyloric stenosis (IHPS). However, these studies are
      limited by confounding by indication, as infants only receive antibiotics when they are ill.

      The investigators proposed an individually randomized trial of azithromycin versus placebo to
      establish the efficacy and safety of administration of a dose of azithromycin during the
      neonatal period. The long-term goal is generate evidence that can be used by neonatal and
      child survival programs related to the use of azithromycin in the youngest children who have
      the highest risk of mortality. The investigators hypothesize that a single dose of
      azithromycin administered in the neonatal period will lead to significantly reduced risk of
      mortality and that this dose will be safe.

      Objectives

        1. Establish the efficacy of a single dose of azithromycin administered during the neonatal
           period compared to placebo in infants 8 to 27 days of life for reduction in all-cause
           mortality.

        2. Establish the safety of a single dose of azithromycin administered during the neonatal
           period.

      This study will be conducted in several regions of Burkina Faso, including peri-urban areas
      of Ouagadougou and Nouna town, and rural areas that are within 4 hours' drive of a pediatric
      facility with capacity for performing pyloromyotomy
    

Eligibility criteria:

        Communities

        Inclusion Criteria:

          -  Within 4 hours of a facility that can provide services for pyloromyotomy (Ouagadougou
             or Bobo Dioulasso)

          -  Accessible during the rainy season

          -  Ultrasound machine available OR a facility in which an ultrasound machine could be
             placed is within 1 hour

        Exclusion Criteria:

          -  Refusal of village chief

        Individuals:

        Inclusion Criteria:

          -  Weight over 2500 g

          -  Able to feed orally

          -  Family intends to stay in study area for at least 6 months

          -  Appropriate consent from at least one caregiver

          -  No known allergy to azalides

          -  Not living within one of the communities included in the community study(CHAT/CHATON)

          -  No hepatic failure manifested by neonatal jaundice

        Exclusion Criteria:

          -  Weight <2500 g

          -  Unable to feed orally

          -  Family planning to move

          -  Mother/caregiver not willing to participate

          -  Allergic to azalides

          -  Living in one of the communities included in the community study (CHAT/CHATON)

          -  Hepatic failure manifested by neonatal jaundice