Azithromycin for Child Survival in Niger: Delivery Trial

Mortality Clinical Trial

— AVENIR  

Official title:

Azithromycin for Child Survival in Niger: Delivery Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774991
• Other study ID #: 19-28387B
• Status: Recruiting
• Phase: Phase 4
• Start date: June 28, 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Elodie Lebas, RN
• Phone: 5104232245
• Email: elodie.lebas[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12057
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

Inclusion Criteria:

At the community-level, eligibility includes:

• Location in one of the 80 Dosso communities randomly selected for the delivery trial
• Population 250 to 2,499*
• Distance > 5 km from the district headquarters town
• Verbal consent of community leader(s)

At the individual-level, eligibility includes:

• Age 1-59 months
• Primary residence in a study community
• Verbal consent of caregiver/guardian for study participation
• Weight = 4 kg Exclusion Criteria:

At the community-level, eligibility includes:

• Inaccessible or unsafe for study team
• "Quartier" designation on national census *Population size as estimated from the most recent national census or projections

At the individual-level, eligibility includes:

• Known allergy to macrolides

Related Conditions & MeSH terms

• Child Health
• Implementation
• Mortality

Intervention

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.

Locations

Country	Name	City	State
Niger	Program National de Santé Oculaire	Niamey

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Coverage	Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population	6 months
Secondary	Program Costs	Program costs as captured by routine administrative data collection during the study period and by micro-costing activities	6 months
Secondary	Fidelity of intervention rollout	Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team	6 months
Secondary	Acceptability of intervention	Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution	6 months