Phase 4
Completed N=864,493
Azithromycin for Child Survival in Niger: Mortality and Resistance Trial
Mortality · Resistance Bacterial · Child, Only
Source: ClinicalTrials.gov NCT04224987 ↗
Enrolled (actual)
864,493
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: All-cause Mortality (1-59 Months Old) — 13.8; 11.9; 13.9 deaths per 1,000 person-years
◆ Published Evidence
Established
45citations · ~23 / year
Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial.
Summary
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.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested.
The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.
Linked Publications (5)
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Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial.
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Spillover of Azithromycin Mass Drug Administration and Child Survival: A Secondary Analysis of a Cluster-Randomized Clinical Trial.
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Mass distribution of azithromycin and child mortality among underweight infants in rural Niger: a subgroup analysis of the AVENIR cluster-randomised trial.
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Predictors of home- vs. facility-based delivery among women living in rural Niger: a cross-sectional survey within the AVENIR cluster-randomised trial.
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Mass azithromycin distribution and antibiotic resistance in the gut and nasopharynx: a cluster-randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality (1-59 Months Old) |
13.8; 11.9; 13.9 | — |
| PRIMARY All-cause Mortality (1-11 Months Old) |
22.3; 18.5; 23.9 | — |
| PRIMARY All-cause Mortality (12-59 Months Old) |
12.2; 10.7; 12.0 | — |
| PRIMARY Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old) |
— | — |
| PRIMARY Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old) |
— | — |
| SECONDARY Mortality Rate by Subgroups: Anthropometric Indicators |
— | — |
| SECONDARY Prevalence of Resistance to Macrolides From Nasopharyngeal Swabs and Load of Genetics Determinants |
— | — |
| SECONDARY Program Costs Per Dose Delivered |
— | — |
Eligibility Criteria
- Intervention
At the community-level, eligibility includes:
Inclusion Criteria
- Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
- Population 250 to 2,499*
- Distance > 5 km from district headquarters town
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
Exclusion criteria
- 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:
Inclusion criteria
- Age 1-59 months
- Primary residence in a study community
- Verbal consent of caregiver/guardian for study participation
- Weight ≥ 3.0 kg (*no weight limits in communities using age-based dosing)
Exclusion criteria
- Known allergy to macrolides
- Population-based sample collections
At the community-level, eligibility includes:
Inclusion Criteria
- Location in Dosso
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
Exclusion criteria
- Inaccessible or unsafe for the study team
- Included in MORDOR trials
- Not randomly selected
- Received treatment prior to sample collection
At the individual-level, eligibility includes:
Inclusion Criteria
- 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
- An individual is not on the list of randomly selected participants from the census
Data sourced from ClinicalTrials.gov (NCT04224987) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.