Improving Care Through Azithromycin Research for Infants in Africa
Status:
Recruiting
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Barcelona Institute for Global Health
Collaborators:
Bill and Melinda Gates Foundation Ministry of Health and Sanitation, Sierra Leone University of Sierra Leone
Treatments:
Azithromycin Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine Vaccines