Clinical trial

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

Name

20-32979

Description

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.

Trial arms

Trial start

2021-10-04

Estimated PCD

2025-01-30

Trial end

2026-01-30

Status

Recruiting

Phase

Early phase I

Treatment

Azithromycin

Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.

Arms:

Biannual mass oral azithromycin + child health days, Resistance Sub Study: Azithromycin + Child Health Days

Other names:

Zithromax

Placebo

Matching identical placebo in packaging, appearance, and taste.

Arms:

Biannual mass placebo + child health days, Resistance Sub Study: Placebo + Child Health Days

Size

694400

Primary endpoint

All-cause mortality

24 months following baseline

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The study will be a double-blind, placebo-controlled, cluster-randomized trial in which health centers (CSPS) in the 3 intervention regions will be randomized to either CHD combined with placebo (33%) or CHD combined with Azithromycin (67%), an allocation of 1:2 that favors active treatment. The allocation sequence and treatment labels will be masked to all but one biostatistician and one analyst at UCSF. The placebo will be indistinguishable from the active azithromycin.\n\nAntimicrobial 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 to CHD+placebo or CHD+azithromycin', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'This will be a quadruple blinded study. Only one biostatistician and one analyst at UCSF will have the unmasking information.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 694400, 'type': 'ESTIMATED'}}

Updated at

2023-06-13

1 organization

1 product

1 drug

1 indication

Organization

University of California, San Francisco

Product

Azithromycin

Indication

Child Mortality

Drug

Varlilumab