NCT04774991

Azithromycin for Child Survival in Niger: Delivery Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10,925 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

Summary

This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.

Detailed description

Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.

Conditions

• Mortality
• Child Health
• Implementation

Interventions

Type	Name	Description
DRUG	Azithromycin for Oral Suspension	Azithromycin will be administered as a single dose in oral suspension form for children as follows: * Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) * For children 1 to \<12 months of age, weight-based dosing will be used * For children 12 to 59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.

Timeline

• Start date: 2021-06-28
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-03-01
• Last updated: 2025-04-24

Locations

1 site across 1 country: Niger