Phase 4
N=190,238
Mortality Reduction After Oral Azithromycin: Mortality Study
Childhood Mortality
Bottom Line
View on ClinicalTrials.gov: NCT02047981 ↗Enrolled (actual)
190,238
Serious AEs
3.5%
Results posted
Jan 2020
Primary outcome: Primary: All-cause Mortality Rate in Children Aged 1-60 Months — 14.6; 16.5 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
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality Rate in Children Aged 1-60 Months |
23.3; 24.0 | — |
| 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 | — |
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.
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). 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.