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Mass Administration of Azithromycin to Infants in Mali to Reduce Mortality
Fadima Cheick Haidara1, Laura Adubra2, Mahamadou Abdou3
1Center for Vaccine Development-Mali, Bamako.
Insights
Mass azithromycin administration to infants in Mali did not lower mortality rates. The study found no significant difference in infant or child mortality between azithromycin and placebo groups, regardless of treatment frequency.
Area of Science:
- Global Health
- Infectious Diseases
- Pediatrics
Background:
- Mass azithromycin administration to children aged 1-59 months has previously reduced mortality in sub-Saharan Africa.
- Previous findings suggested the largest impact was on infants under 12 months within 3 months post-treatment.
- This observation prompted a trial to further investigate azithromycin's impact on infant mortality.
Purpose of the Study:
- To evaluate the efficacy of mass azithromycin administration in reducing infant and child mortality in Mali.
- To compare the effects of twice-yearly versus quarterly azithromycin distribution against a placebo control.
- To assess mortality rates specifically in infants aged 1 to 11 months.
Main Methods:
- A randomized trial involving 1151 villages in Mali, assigning them to placebo, twice-yearly azithromycin, or quarterly azithromycin groups.
- Infants aged 1-11 months received azithromycin (20 mg/kg) or placebo every 3 months.
- The primary outcome was death within 3 months post-eligibility, analyzed using intention-to-treat principles.
Main Results:
- No significant reduction in mortality was observed in the azithromycin groups compared to the placebo group.
- Mortality rates per 1000 person-years were 11.9 (control), 11.8 (twice-yearly azithromycin), and 11.3 (quarterly azithromycin).
- Adverse events were rare and similarly distributed across all groups; mortality in older children (12-59 months) was also comparable.
Conclusions:
- Mass administration of azithromycin limited to infants aged 1-11 months in Mali did not reduce overall infant or child mortality.
- Neither twice-yearly nor quarterly azithromycin delivery demonstrated a mortality benefit compared to placebo.
- The findings suggest that targeted mass azithromycin distribution may not be effective in this specific context for reducing mortality.
Background:
Mass administration of azithromycin to children 1 to 59 months of age has been shown to reduce mortality among infants and children in this age group in some areas of sub-Saharan Africa. The largest effects have appeared to be among infants younger than 12 months of age, within 3 months after treatment; this observation motivated the design of the current trial.
Methods:
In this trial, we randomly assigned villages in Mali, West Africa, in a 3:4:2 ratio to receive distributions of placebo, azithromycin two times a year, or azithromycin four times a year. Infants 1 to 11 months of age received, in doses of 20 mg per kilogram of body weight, placebo every 3 months (control group); azithromycin at two quarterly visits from January through June and placebo at two quarterly visits from July through December (twice-yearly azithromycin group); or azithromycin every 3 months (quarterly azithromycin group). The primary outcome was death within 3 months after eligibility had been confirmed, analyzed in the intention-to-treat population.
Results:
From December 2020 through December 2022, a total of 1151 villages were enrolled in the trial; 386 villages were randomly assigned to the control group, 511 to the twice-yearly azithromycin group, and 254 to the quarterly azithromycin group. Among all the villages, 149,090 infants received at least one dose of placebo or azithromycin, with a total of 82,600 person-years of follow-up; 968 deaths were recorded. Mortality was 11.9 deaths per 1000 person-years at risk in the control group, 11.8 deaths per 1000 person-years in the twice-yearly azithromycin group (incidence rate ratio, 1.00; 95% confidence interval [CI], 0.83 to 1.19), and 11.3 deaths per 1000 person-years in the quarterly azithromycin group (incidence rate ratio, 0.93; 95% CI, 0.75 to 1.15). Adverse events were rare, and the percentages of infants with adverse events were similar in the three groups. Mortality among untreated children 12 to 59 months of age was similar across groups.
Conclusions:
Mass administration of azithromycin in Mali, limited to infants 1 to 11 months of age, did not result in lower infant or child mortality than placebo, regardless of whether azithromycin was delivered twice yearly or quarterly. (Funded by the Gates Foundation; LAKANA ClinicalTrials.gov number, NCT04424511.).
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