Trial reportThe New England journal of medicine2025
Mass Administration of Azithromycin to Infants in Mali to Reduce Mortality.
Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04424511 (LAKANA , a Cluster-randomized, Double-blinded, Parallel Group, Controlled Trial, Testing the Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Rural Mali.), which is not on this map. Cited by 5 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
LAKANA , a Cluster-randomized, Double-blinded, Parallel Group, Controlled Trial, Testing the Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Rural Mali.
Who cites it
5 citing papers in PubMed.
- Infant Growth After Mass Administration of Azithromycin: Secondary Outcomes of a Cluster Randomized Clinical Trial.JAMA network open · 2026Trial
- EBNEO Commentary: The LAKANA Trial: Mass Administration of Azithromycin to Infants in Mali Did Not Reduce Mortality.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Micro-costing for national-scale azithromycin mass drug administration to improve child survival in Niger.PLOS global public health · 2026Article
- Azithromycin mass drug administration to reduce childhood mortality in humanitarian crises.PLOS global public health · 2026Review
- A single dose of azithromycin versus placebo for malaria in infants: A cluster-randomized trial.PLOS global public health · 2026Article
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Authors and funding
26 authors.
Funding
Abstract
backgroundMass 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.
methodsIn 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.
resultsFrom 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.
conclusionsMass 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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