Recruitment began for the ICARIA clinical trial, which aims to evaluate whether the administration of azithromycin alongside intermittent preventive treatment of malaria in infants reduces child mortality
SDG Target 3.2: end preventable deaths of newborns and children under five years of age by 2030.
SDG Target 3.2: end preventable deaths of newborns and children under five years of age by 2030.
Most of the estimated 2.5 million deaths each year in children under five in sub-Saharan Africa are due to infectious diseases. With the overall aim of preventing many of these deaths, an international consortium coordinated by Clara Menéndez and her team launched the ICARIA project in 2019 with the goal of testing whether giving an antibiotic (azithromycin) in addition to the preventive treatment against malaria in infants (IPTi) reduces child mortality. The five-year project, funded by the Bill & Melinda Gates Foundation and the ”la Caixa” Foundation, takes place in Sierra Leone, a malaria-endemic country with one of the highest child mortality rates in the world: for every 1000 children born alive, around 120 will die before reaching the age of five.
Recruitment, capacity building and community engagement
After almost two years of careful preparation, the first trial participants (infants under 18 months of age) were recruited on 17 March in Tonkolili, a district of the Northern Province. By late 2021, 20% of the 20,560 participants needed for the trial had already been recruited. “This is the first individually randomised placebo-control design to evaluate the effect of IPTi together with azithromycin,” says Menéndez. The innovative aspect of the approach is to deliver the drugs through the immunisation programme, which now includes an additional visit at 15 months of age for a booster of the measles vaccine.
But recruitment is not everything. “In addition to starting the clinical trial, this year we have continued to build and reinforce capacities among local healthcare workers and staff in different aspects of a trial, such as data management, administration, human resources, good clinical practices and monitoring of drug resistance,” says project manager Anna Lucas. “And we also have been busy with another vital activity in this kind of project: engaging with local communities,” she adds. All this is possible thanks to valuable help from local partners: the College of Medicine and Allied Health Sciences at the University of Sierra Leone and the Ministry of Health and Sanitation.
ICARIA’s approach has the potential to save many lives. Whether it works, is feasible, and can be scaled up to other countries in Africa, the next few years will tell.
