Summary

Eligibility
for people ages 1 month to 11 months (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Thomas Lietman, MD
Photo of Thomas Lietman
Thomas Lietman

Description

Summary

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

Official Title

Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine

Details

The MORDOR clinical trial funded by the Bill & Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.

Keywords

Child Mortality Azithromycin Mass Drug Administration

Eligibility

You can join if…

Open to people ages 1 month to 11 months

Community eligibility criteria:

  • Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins)
  • Verbal consent of the community leader is obtained

Inclusion criteria for children:

  • Aged 1 to 11 months
  • Living in one of the communities participating in the study

You CAN'T join if...

Community exclusion criteria:

• Inaccessible or unsafe for the study team

Exclusion criteria for children:

• Known allergy to macrolides

Locations

  • University of California, San Francisco
    San Francisco California 94158 United States
  • Centre de Recherche en Sante de Nouna
    Nouna Burkina Faso
  • Helen Keller International
    Ouagadougou Burkina Faso

Lead Scientist at UCSF

  • Thomas Lietman, MD
    Professor, Proctor Foundation. Authored (or co-authored) 370 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04716712
Phase
Phase 4
Study Type
Interventional
Last Updated