Clinical trial

The Resiliency Through Azithromycin for Children Project: Implementation Research on Bi-Annual Mass Distribution of Azithromycin to Children 1-11 Months in Côte d'Ivoire

Name

1743615

Description

REACH2 is a three-year implementation research study designed to examine the implementation through a mass drug administration platform of bi-annual single-dose azithromycin to reduce child mortality among children ages 1 to 11 months who reside in high child mortality settings.

Trial arms

Trial start

2021-08-27

Estimated PCD

2024-02-28

Trial end

2024-02-28

Status

Recruiting

Treatment

Single-dose azithromycin

Bi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months.

Arms:

Bi-annual single dose azithromycin

Size

140000

Primary endpoint

% of eligible population covered by intervention

three years

Infant mortality rate

three years

Implementation fidelity

three years

Eligibility criteria

Inclusion Criteria: * Ages 1 to 11 months * Resident in targeted community Exclusion Criteria: * Children below 3.0 kg (3rd centile for healthy 1-month old infants in the WHO growth charts) * Appears seriously ill at the time of the MDA (per the CDD's assessment) * Unable to swallow liquid delivered through a needle-less syringe because of physical limitations * Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide * prior allergic reaction to medication likely to be a macrolide

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140000, 'type': 'ESTIMATED'}}

Updated at

2024-02-08

1 organization

1 product

1 indication

Organization

FHI 360

Product

Azithromycin

Indication

Child Mortality