Toto Bora, an expression meaning “healthy baby” in Kiswahili, enrolled its first pediatric patient today in a research trial aimed at reducing childhood morbidity and mortality in the months after a hospitalization.
In sub-Saharan Africa, childhood mortality remains unacceptability high. Children who are hospitalized and subsequently discharged are a group of children at particularly high risk, yet few interventions exist for the post-discharge period. A recent trial found that the mass drug administration of azithromycin reduced childhood mortality by half among children in Ethiopia in communities receiving the intervention. The Toto Bora team, led by Drs. Judd Walson, MD, MPH and Patricia Pavlinac, PhD MS, believes that children being discharged from hospital represent an accessible high-risk population in which targeted use of this broad-spectrum antibiotic may have dramatic impact.
In this double-blind, placebo-controlled trial, children discharged from hospitals in Kisii and Homa Bay counties of Kenya are randomized to a 5-day course of azithromycin or placebo and followed for six months to determine the efficacy of azithromycin in reducing post-discharge morbidity and mortality. Stool, nasopharyngeal swabs, and blood samples are also being collated from children to evaluate the effect of the intervention on enteric and nasopharyngeal infections, malaria, the gut microbiome, and systematic inflammation. The emergence of antibiotic resistance among treated individuals and their primary caregivers will also be assessed and cost-effectiveness analyses performed to inform policy decisions.
The Toto Bora Trial began enrollment on June 28, 2016 and is estimated to be complete data collection in June 2019. Congratulations to this Global WACh team for launching this important study to generate evidence on effective interventions to reduce childhood mortality in Kenya!
Read more about Toto Bora on the clinicaltrials.gov website: