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

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

Conditions

• Childhood Mortality

Interventions

DRUG

Azithromycin

a single dose of Azithromycin will be administered to infants between their 8-27th days of life

DRUG

Placebo

a single dose of Placebo will be administered to infants between their 8-27th days of life

Sponsors & Collaborators

• Centre de Recherche en Sante de Nouna, Burkina Faso

  collaborator OTHER_GOV

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Catherine E Oldenburg, PhD · University of California, San Francisco

• Tom M Lietman, MD · University of California, San Francisco

• Ali Sie, MD, PhD · Centre de Recherche en Sante de Nouna, Burkina Faso

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Days

Max Age

27 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-11

Primary Completion

2022-05-01

Completion

2022-12-31

FDA Drug

Yes

Countries

• Burkina Faso

Study Locations