Azithromycin Program to Improve Child Survival and Monitor Antibiotic Resistance in Niger

What this Trial Is About

Researchers are evaluating the impact of mass drug administration MDA of azithromycin on child survival and antimicrobial resistance AMR in Niger. This adaptive platform trial aims to monitor under-5 mortality rates and AMR as the azithromycin program expands nationwide. The study also assesses how long the benefits of azithromycin MDA last considering the potential risk of increasing AMR, following World Health Organization guidelines for ongoing monitoring. Participants receive azithromycin distributed door-to-door to children aged 1 to 59 months by community health workers. The trial includes three groups continuous azithromycin distribution for four years, delayed distribution starting after two years, and stopping distribution after two years. The trial uses cluster randomization and plans re-randomization every two years to adapt interventions as needed. Throughout the study, researchers will monitor all-cause mortality at two and four years, along with resistance to macrolides found in nasopharyngeal and rectal swabs. Additional assessments include tracking infectious clinic visits and program costs. Participants and communities will be observed and tested regularly to understand the balance between azithromycins benefits and the development of antimicrobial resistance over time.

Azithromycin for Child Survival in Niger II