Azithromycin for Child Survival in Niger II

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Apr 8, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Azithromycin for Child Survival in Niger II" is studying how the medication azithromycin can help reduce child mortality in Niger while also keeping track of any potential increase in antimicrobial resistance (AMR), which is when bacteria become resistant to antibiotics. The World Health Organization recommends that when azithromycin is given to communities, it should be accompanied by careful monitoring of both child deaths and AMR. This trial is part of a larger program that aims to improve child health in rural areas of Niger and will adapt its approach based on what is learned every two years.

To participate in the trial, individuals must live in designated rural areas involved in the program and provide verbal approval to join. Women aged 12 to 55 years old can be included for monitoring child mortality, while children between 1 month and 59 months old can be included for monitoring AMR, with approval from a parent or guardian. Participants can expect to be part of a community effort to improve child health, and their involvement will help researchers understand the benefits and risks of using azithromycin in this way. It’s important to note that individuals with an allergy to macrolides, a group of antibiotics that includes azithromycin, cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• CSI-level for mortality and AMR monitoring:
• • Located in a region participating in the program
• • Designated as rural by local study team
• • Selected for participation in monitoring activities
• • Safe and accessible for study teams
• • Verbal approval from community leaders
• Individual level for mortality monitoring:
• • Residing in the catchment area of an eligible CSI
• • Selected for participation in monitoring activities
• • Female
• • Age between 12 and 55 years old
• • Verbal approval from participant
• Individual-level for AMR monitoring:
• • Residing in the catchment area of an eligible CSI
• • Selected for participation in monitoring activities
• • Age between 1 and 59 months old
• • Verbal approval from a caregiver or guardian
• Exclusion Criteria:
• At the community-level:
• • Designated as urban by local study team
• • Inaccessible or unsafe for study team
• At the individual-level:
• • Known allergy to macrolides