Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Centre de Recherche en Sante de Nouna, Burkina Faso
• Treatments: Azithromycin

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