Researchers at the University of Washington School of Public Health are working to determine if antibiotics could help save thousands of children from dying of diarrheal disease, thanks to a four-year, $2.5 million grant from the World Health Organization.
Investigators from the Department of Global Health’s Global Center for Integrated Health of Women, Adolescent, and Children (Global WACh) and Kenya Medical Research Institute will lead the Kenya field site of this multi-country trial under leadership from the WHO Maternal, Newborn, Child, & Adolescent Health Research and Development Team.
Dr. Judd Walson, associate professor of global health and adjunct associate professor of epidemiology, is principal investigator for the project. The research is part of the Antibiotics for Children with Severe Diarrhea (ABCD) Trial, the largest clinical trial addressing diarrhea management to date. It seeks to not only answer the question of the potential benefits of antibiotics, but also to address any potential harm, such as antibiotic resistance.
“That children continue to die from diarrhea is unacceptable,” said Dr. Patty Pavlinac, acting assistant professor of global health and one of the lead researchers. “While interventions such as oral rehydration solution, therapeutic zinc, and rotavirus vaccination have achieved great success in reducing diarrhea deaths attributed to the dehydrating effects of diarrhea, young children with bacterial causes of diarrhea experience other severe consequences, including malnutrition, gastrointestinal dysfunction, and death, which are unaddressed with existing interventions.”
The project aims to determine the efficacy of two antibiotics in reducing risk of death in children less than two years of age with diarrhea and dehydration or malnutrition through a double-blind placebo-controlled clinical trial. A total of 15,000 children will be enrolled from study sites in seven countries (Kenya, Mali, Malawi, Tanzania, Bangladesh, India and Pakistan) and randomly assigned to a three-day course of azithromycin, ciprofloxacin, or placebo. Children will then be followed for 90 days to assess risk of death or chronic malnutrition.
A subset of children will be followed for an additional three months, along with another child in their household, to determine the long-term impact of the antibiotics on potential antimicrobial resistance, and to evaluate any potential impact on their intestinal health.