Infant Mortality Reduction by the Mass Administration of Azithromycin (MIRAMA)

University of California San Francisco (UCSF)

Status and phase: Active, not recruiting; Phase 4

Conditions: Child Mortality

Treatments: Drug: Azithromycin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04716712

20-32979

Details and patient eligibility

About

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.

Full description

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.

In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.

Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.

Enrollment: 694,400 estimated patients

Sex: All

Ages: 1 to 11 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Community exclusion criteria:

• Inaccessible or unsafe for the study team

Exclusion criteria for children:

• Known allergy to macrolides

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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694,400 participants in 4 patient groups, including a placebo group

Biannual mass oral azithromycin + child health days

Active Comparator group

Description:

Bi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform

Treatment:

Drug: Azithromycin

Biannual mass placebo + child health days

Placebo Comparator group

Description:

Bi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform

Treatment:

Drug: Placebo

Resistance Sub Study: Azithromycin + Child Health Days

Active Comparator group

Description:

Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion

Treatment:

Drug: Azithromycin

Resistance Sub Study: Placebo + Child Health Days

Placebo Comparator group

Description:

Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion

Treatment:

Drug: Placebo