Phase 4
N=66,228
Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
Childhood Mortality
Bottom Line
View on ClinicalTrials.gov: NCT03338244 ↗Enrolled (actual)
66,228
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: All-cause Mortality Rate in Children Aged 1-60 Months — 24.8; 26.7 deaths per 1000 person years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality Rate in Children Aged 1-60 Months |
24.8; 26.7 | — |
| PRIMARY Macrolide Resistance in Children Aged 1-60 Months |
— | — |
| PRIMARY Normalized Macrolide Resistance in Children Aged 1-60 Months |
79.85; 15.79 | — |
| SECONDARY Microbial Composition of Stool |
— | — |
| SECONDARY Campylobacter and Other Pathogenic Organisms in Stool |
— | — |
Summary
MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.
Eligibility Criteria
Inclusion Criteria
- Communities- All communities eligible for MORDOR (NCT02047981)
- Individuals-All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census
Exclusion Criteria
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Data sourced from ClinicalTrials.gov (NCT03338244). 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.