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Completed

NCT Number: NCT04774991

Azithromycin for Child Survival in Niger: Delivery Trial

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.

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Key information

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Program National de Santé Oculaire

Niamey, Niger

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin for Oral Suspension

Drug

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.

Other names: Zithromax

Primary outcomes

  1. Treatment Coverage

    Time frame: 6 months

    Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population

Secondary outcomes

  1. Program Costs

    Time frame: 6 months

    Program costs as captured by routine administrative data collection during the study period and by micro-costing activities

  2. Fidelity of intervention rollout

    Time frame: 6 months

    Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team

  3. Acceptability of intervention

    Time frame: 6 months

    Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger

Registry information

Acronym: AVENIR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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