Phase 4
N=77,664
Community Health Azithromycin Trial in Burkina Faso
Childhood Mortality
Bottom Line
View on ClinicalTrials.gov: NCT03676764 ↗Enrolled (actual)
77,664
Serious AEs
0.2%
Results posted
Feb 2025
Primary outcome: Primary: All-cause Mortality Rate in Children Aged 1-59 Months — 8.2; 10.0 deaths per 1000 person years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug); Placebos (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality Rate in Children Aged 1-59 Months |
8.2; 10.0 | — |
| PRIMARY All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age |
82; 75 | — |
| SECONDARY Malaria Parasitemia in Children 1-59 Months at 36 Months |
90; 114 | — |
| SECONDARY Weight-for-height Z-score in Individually Randomized Children at Healthy Child Visits |
-0.64; -0.64 | — |
| SECONDARY Height-for-age Z-score in Individually Randomized Children at Healthy Child Visits |
-0.31; -0.31 | — |
| SECONDARY Mid-upper Arm Circumference in Individually Randomized Children at Healthy Child Visits |
13.8; 13.8 | — |
| SECONDARY Linear Growth in Individually Randomized Children |
8.0; 8.0 | — |
| SECONDARY Weight Gain in Individually Randomized Children |
18; 18 | — |
Summary
An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality. We recently demonstrated the biannual mass azithromycin distribution significantly reduces all-cause child mortality in a cluster randomized trial (MORDOR I) conducted in three diverse regions of Sub-Saharan Africa.
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and mortality. We propose a cluster randomized trial designed to repeat the original study to confirm the original results in a different geographic study with similarly high child mortality, and to better understand the mechanism behind any effect of azithromycin on child mortality. We hypothesize that biannual mass azithromycin distribution will reduce child mortality compared to placebo, and that this effect will be primarily driven by a reduction in infectious burden.
Objectives:
1. Determine the efficacy of biannual mass azithromycin distribution versus placebo in children aged 1-59 months for reduction in all-cause mortality.
2. Determine the efficacy of targeted azithromycin distribution to infants during an early infant healthcare visit (approximately 5th through 12th week of life) on infant mortality.
3. Determine the mechanism behind the effect of biannual mass azithromycin distribution for reduction in child mortality.
The study will be conducted in the Nouna District in northwestern Burkina Faso.
Eligibility Criteria
Communities:
Inclusion Criteria
- The community location in target district.
- The community leader consents to participation in the trial (this does not obviate the need for individual consent, but without overall leadership consent, the community as a whole cannot be part of the trial).
- Eligible communities estimated population of between 200-2,000 people
- The community is not in an urban area
Exclusion criteria
- Refusal of village chief
Individuals:
Inclusion Criteria
- All children in the study communities aged 5 to 12 weeks old at the time of the vaccination visit are eligible to participate
- Ability to feed orally
- Appropriate consent from at least one caregiver
- Family intends to stay within the study area
Exclusion Criteria
- Individuals allergic to macrolides or azalides will not be given the study antibiotic azithromycin, but will be included in the outcome
- Refusal of parent or guardian
- Child unable to orally feed
- Family planning to move
- Children younger than 28 days old or older than 12 weeks
- Children in the bi annual drug administration group who weight less than 3.8kg.
Data sourced from ClinicalTrials.gov (NCT03676764). 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.