Study of Azithromycin Treatment for Non-Bloody Shigella Diarrhea in Children Aged 6 to 59 Months in Bangladesh and Zambia

What this Trial Is About

Researchers are evaluating whether treating children with non-dysentery Shigella-associated watery diarrhea NDSD with antibiotics improves their clinical outcomes and growth. This study focuses on children aged 6 to 59 months who seek care for diarrhea at hospitals in Bangladesh and Zambia. It is a phase 2B, randomized, double-blind, placebo-controlled study aiming to address if antibiotic treatment benefits this group beyond current World Health Organization guidelines, which recommend antibiotics mainly for dysentery or cholera cases. Participants will be randomly assigned to receive either Azithromycin at a dose of 10 mgkg once daily for five days or a placebo that looks like the medication but contains no active drug. All children will receive standard rehydration therapy and zinc supplementation as part of routine care. Following treatment, children will be monitored for three months through household visits to track health outcomes and growth. During the study, researchers will assess the time it takes for diarrhea to stop and the time to clear the Shigella infection based on stool tests. They will also measure changes in weight-for-age and length-for-age scores over 90 days to evaluate growth. Data collection includes morbidity monitoring and anthropometric measurements. Safety and adherence to the study protocol will be observed throughout the follow-up period, which lasts about three months after enrollment.

The Impact of Shigellosis and Recommended Treatment in Children