{"id":"nct:NCT04424511","kind":"trial","title":"Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali","authors":["Tampere University"],"author_count":1,"year":2020,"published":"2020-06-11","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT04424511","source_url":"https://clinicaltrials.gov/study/NCT04424511","archive_url":"https://space-kitty.com/papers/nct:NCT04424511","updated":"2025-05-21","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"The LAKANA trial will assess the impact on mortality and other health outcomes of quarterly and biannual azithromycin mass drug administration (MDA) when delivered to 1-11-month (29-364 days) old infants in a high-mortality setting where malaria is holoendemic but there is also a functioning seasonal malaria chemoprevention (SMC) program in place. The long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality, and to determine the most effective treatment regimen. The main study hypotheses in terms of mortality effect are: i) Biannual azithromycin MDA to 1-11 month old infants reduces their mortality, ii) Quarterly azithromycin MDA to 1-11 month old infants reduces their mortality, iii) Quarterly azithromycin MDA has a bigger mortality effect than biannual MDA.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"peer_reviewed":null,"categories":["Mortality"],"details":{"acronym":"LAKANA","status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":149201,"sponsor":"Tampere University","conditions":["Mortality"],"interventions":["DRUG: Placebo","DRUG: Azithromycin"],"start_date":"2020-10-15","start_date_type":"ACTUAL","primary_completion_date":"2024-12-31","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"infectious-disease-amr","name":"Infectious Disease, Vaccines & Antimicrobial Resistance","domain_slug":"medicine"}],"cited_in_dossiers":[]}