Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

169707 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-15

Brief Summary

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The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.

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Detailed Description

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In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .

All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.

Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Conditions

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Resistance Bacterial Morality Child Health Implementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster-randomized trial with response adaptive allocation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants, investigators, and program implementers will not be actively masked from the study arm allocation given that no placebo will be used. Outcome assessors and data analysts will be masked.

Study Groups

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Programmatic azithro 1-11

Biannual oral azithromycin administration to children aged 1-11 months distributed by 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 (up to the maximum adult dose of 1g).

Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.

no intervention

No additional intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Azithromycin for Oral Suspension

Azithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g).

Dosage will be calculated by age for children aged 1-5 months. For children 6-59 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

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Zithromax

Eligibility Criteria

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Inclusion Criteria

* Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

* Age 1-11 months
* Primary residence in a study community
* Verbal consent of caregiver/guardian for study participation

* Location in study region
* Distinguishable from neighboring communities
* Verbal consent of community leader(s)

* Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
* Primary residence in a study community selected for sample collections
* Verbal consent of caregiver/guardian for study participation

Exclusion Criteria

* Inaccessible or unsafe for study team
* "Quartier" designation on national census

At the individual-level, eligibility includes:

* Known allergy to macrolides

Population-based sample collections

At the community-level, eligibility includes:

* Inaccessible or unsafe for study team
* Included in MORDOR trials
* Not randomly selected

At the individual-level, eligibility includes:

* Not on list of randomly selected participants from the census

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes