Phase 4
Completed N=190,238
Mortality Reduction After Oral Azithromycin: Mortality Study
Childhood Mortality
Source: ClinicalTrials.gov NCT02047981 ↗
Enrolled (actual)
190,238
Serious AEs
3.5%
Results posted
Jan 2020
Primary outcomePrimary: All-cause Mortality Rate in Children Aged 1-60 Months — 14.6; 16.5 deaths per 1000 person-years
◆ Published Evidence
Established
46citations · ~12 / year
Impact of azithromycin mass drug administration on the antibiotic-resistant gut microbiome in children: a randomized, controlled trial.
Summary
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.
Linked Publications (5)
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Impact of azithromycin mass drug administration on the antibiotic-resistant gut microbiome in children: a randomized, controlled trial.
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Prolonged mass azithromycin distributions and macrolide resistance determinants among preschool children in Niger: A sub-study of a cluster-randomized trial (MORDOR).
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Assessment of Spillover of Antimicrobial Resistance to Untreated Children 7-12 Years Old After Mass Drug Administration of Azithromycin for Child Survival in Niger: A Secondary Analysis of the MORDOR Cluster-Randomized Trial.
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Distance to Health Centers and Effectiveness of Azithromycin Mass Administration for Children in Niger: A Secondary Analysis of the MORDOR Cluster Randomized Trial.
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Co-selection of genetic antibiotic resistance in <i>Streptococcus pneumoniae</i> after repeated azithromycin mass drug administrations in Niger.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality Rate in Children Aged 1-60 Months |
23.3; 24.0 | — |
| SECONDARY Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only) |
0.22; 0.23; 0.39; 0.42; 0.12; 0.12 | — |
| SECONDARY Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death |
853; 0 | — |
| SECONDARY All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children |
5229; 7647 | — |
| SECONDARY Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only) |
0.46; 0.90; 0.47; 0.56; 0.29; 0.29 | — |
| SECONDARY Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only) |
1.15; 1.40; 3.68; 3.84; 1.06; 1.54 | — |
Eligibility Criteria
Inclusion Criteria
Communities
- The community location in target district.
- The community leader consents to participation in the trial
- The community's estimated population is between 200-2,000 people.
- The community is not in an urban area.
Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.
Exclusion Criteria
Individuals
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Data sourced from ClinicalTrials.gov (NCT02047981) 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.