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We conducted a randomized, controlled, parallel-group study of artemisinin-based combination therapy (ACT) in Mananjary and Farafangana, two localities on the rainy south-east coast of Madagascar, from March to September 2018. The efficacy and safety of artesunate + amodiaquine (ASAQ) and artemether + lumefantrine (AL) were assessed according to the WHO protocol with a 28-day follow-up. Children aged 6 months to 14 years with uncomplicated <jats:italic>Plasmodium falciparum<\/jats:italic> malaria were randomized to receive ASAQ or AL for three days (1:1). 347\/352 (98.5%) randomized patients reached the study endpoint on day 28. Crude adequate clinical and parasitological response (ACPR) rates were 100% (95% CI: 98.8\u2013100%) in the ASAQ group and 96% (95% CI: 93.1\u201398.9%) in the AL group (per protocol population). However, the PCR-corrected ACPR rate was 97.7% (95% CI: 95.4\u2013100%) in the AL group. Two cases of recrudescence and three of re-infection were observed. Mild and moderate adverse events, including gastrointestinal and\/or nervous disorders, were reported in 11.9% (42\/352) of patients. We found that ASAQ and AL were safe and efficacious for treating uncomplicated <jats:italic>P. falciparum<\/jats:italic> malaria. They may be used for treatment at health facilities and at the community level, and for mass drug administration campaigns.<\/jats:p>","DOI":"10.1051\/parasite\/2023034","type":"journal-article","created":{"date-parts":[[2023,8,30]],"date-time":"2023-08-30T08:08:05Z","timestamp":1693382885000},"page":"32","source":"Crossref","is-referenced-by-count":3,"title":["Therapeutic efficacy and safety of artesunate + amodiaquine and artemether + lumefantrine in treating uncomplicated <i>Plasmodium falciparum<\/i> malaria in children on the rainy south-east coast of Madagascar"],"prefix":"10.1051","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8686-8411","authenticated-orcid":false,"given":"Judicka\u00eblle","family":"Irinantenaina","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0656-0557","authenticated-orcid":false,"given":"Gw\u00e9na\u00eblle","family":"Carn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6196-8504","authenticated-orcid":false,"given":"Dina Ny Aina Liantsoa","family":"Randriamiarinjatovo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6690-2945","authenticated-orcid":false,"given":"Aina Nirina","family":"Harimanana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9781-3295","authenticated-orcid":false,"given":"Seheno","family":"Razanatsiorimalala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Ralemary","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurice","family":"Randriarison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celestin","family":"Razafinjato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2865-6436","authenticated-orcid":false,"given":"Raphael","family":"Hotahiene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2767-0349","authenticated-orcid":false,"given":"Milijaona","family":"Randrianarivelojosia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"250","published-online":{"date-parts":[[2023,8,30]]},"reference":[{"issue":"1","key":"R1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s12936-019-2848-1","volume":"18","author":"Abuaku","year":"2019","journal-title":"Malaria Journal"},{"key":"R2","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1056\/NEJMoa1314981","volume":"371","author":"Ashley","year":"2014","journal-title":"New England Journal of Medicine"},{"key":"R3","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1111\/j.1365-3156.2006.01784.x","volume":"12","author":"Ashley","year":"2007","journal-title":"Tropical Medicine & International Health"},{"key":"R4","unstructured":"CREAM. 2013. 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