Azithromycin for Child Survival in Niger: Delivery Trial

NCT ID: NCT04774991

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10925 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2023-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azithro 1-59 fixed point

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

Group Type: ACTIVE_COMPARATOR

Azithromycin for Oral Suspension

Intervention Type: 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.

Azithro 1-59 door-to-door

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

Group Type: ACTIVE_COMPARATOR

Azithromycin for Oral Suspension

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zithromax

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom M Lietman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kieran S O'Brien, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Program National de Santé Oculaire

Niamey, , Niger

Countries

Niger

References

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.

Reference Type: DERIVED

PMID: 37967058 (View on PubMed)

Other Identifiers

19-28387B

Identifier Type: -

Identifier Source: org_study_id