Azithromycin for Child Survival in Niger: Delivery Trial

NCT04774991 | Completed Phase 4 DMC

• 1 other identifier: 19-28387B
• Study Type: interventional
• Target: 10,925
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mortality; Child Health; Implementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Program Costs

  6 months

• Fidelity of intervention rollout

  6 months

• Acceptability of intervention

  6 months

Study Arms (2)

Azithro 1-59 fixed point

ACTIVE COMPARATOR

Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers

Drug: Azithromycin for Oral Suspension

Azithro 1-59 door-to-door

ACTIVE COMPARATOR

Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers

Drug: Azithromycin for Oral Suspension

Interventions

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.

Also known as: Zithromax

Azithro 1-59 door-to-door; Azithro 1-59 fixed point

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Bill and Melinda Gates Foundation: collaborator
• Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger: collaborator

Study Sites (1)

Program National de Santé Oculaire

Niamey, Niger

Location

Related Publications (1)

• Arzika AM, Maliki R, Amza A, Karamba A, Gallo N, Aichatou B, Sara II, Beidi D, Haroun LM, Oumarou F, Lebas E, Peterson B, Colby E, Nguyen W, Liu Z, Fitzpatrick MC, Arnold BF, Lietman TM, O'Brien KS; AVENIR Study Group. Comparison of door-to-door and fixed-point delivery of azithromycin distribution for child survival in Niger: A cluster-randomized trial. PLOS Glob Public Health. 2023 Nov 15;3(11):e0002559. doi: 10.1371/journal.pgph.0002559. eCollection 2023.

  PMID: 37967058 DERIVED

MeSH Terms

Interventions

Azithromycin; Suspensions

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Tom M Lietman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kieran S O'Brien, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the delivery trial, participants, implementers, and outcome assessors will not be actively masked from the delivery approach given the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The AVENIR delivery trial is a two-armed, cluster-randomized trial in the Dosso region in Niger. 80 Communities will be randomized in a 1:1 allocation to either door-to-door delivery or fixed-point delivery of azithromycin to children 1-59 months of age.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: June 28, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data will be made available after publication of the outcomes and will be made available indefinitely
• Access Criteria: Once made available, the data will be open access.

Locations

NI (1)