Improving Care Through Azithromycin Research for Infants in Africa

Summary

Infectious diseases are among the most common causes of mortality in the over 2.5 million children under 5 years of age (U5) who died in 2018 in sub-Saharan Africa (SSA). New approaches to treatment and prevention of these diseases are needed to increase child survival. Sierra Leone has one of the highest rates of under-five child mortality in the world. It is estimated that 32,000 children die each year, the leading causes being neonatal conditions, malaria, pneumonia and diarrhea. In Sierra Leone, the available information on malaria indicates that it accounts for 38% of deaths among under-five children. Reducing the prevalence and impact of the disease among the general population is a major priority of the Ministry of Health and Sanitation (MoHS) of Sierra Leone .

Intermittent Preventative Treatment in infants (IPTi) - the administration of a full course antimalarial treatment to infants at individual timepoints regardless of infection status- has been shown to reduce clinical malaria and anemia in infants in the first year of life . When delivered alongside the Expanded Program on Immunization (EPI), IPTi with Sulphadoxine-pyrimethamine (SP) is a highly cost-effective intervention. . Sierra Leone is currently the only country that implements nationwide the World Health Organization's (WHO) IPTi guideline, which is administered within the first year of life. However, its benefit when expanded into the second year of life remains unknown. Taking the advantage of the inclusion in the EPI program of a booster dose of measles vaccine at 15 months of age, the ICARIA trial will also assess the efficacy of adding a dose of IPTi-SP at this age.

Recent studies show that azithromycin (AZi) - a macrolide antibiotic with some antimalarial effect- is associated with a significant reduction in childhood mortality when used in mass drug administration (MDA) for trachoma elimination in areas of sub-Saharan Africa (SSA) with child mortality rates far beyond Sustainable Development Goals , . However, despite the potential benefit of the intervention several fundamental scientific questions need to be answered before it can be recommended for large-scale implementation.

Conditions

• Child Mortality

Interventions

DRUG

Azithromycin

Administration of azithromycin during the first 15 months of life through the Expanded Program on Immunisation

DRUG

Placebo

Administration of placebo during the first 15 months of life through the Expanded Program on Immunisation

Sponsors & Collaborators

• University of Sierra Leone

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Ministry of Health and Sanitation, Sierra Leone

  collaborator OTHER_GOV

• La Caixa Foundation

  collaborator OTHER

• Barcelona Institute for Global Health

  lead OTHER

Principal Investigators

• Clara Menendez, MD, PhD · Barcelona Institute for Global Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2025-09-11

Completion

2026-04-30

Countries

• Sierra Leone

Study Locations