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To assess efficacy of currently used ACT, an in vivo therapeutic efficacy study was conducted.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The study was conducted in four sentinel sites: Montepuez, Moatize, Mopeia and Massinga. Patients between 6 and 59\u00a0months old with uncomplicated <jats:italic>Plasmodium falciparum<\/jats:italic> malaria (2000\u2013200,000\u00a0parasites\/\u00b5l) were enrolled between February and September of 2018, assigned to either an AL or AS\u2013AQ treatment arm, and monitored for 28\u00a0days. A Bayesian algorithm was applied to differentiate recrudescence from new infection using genotyping data of seven neutral microsatellites. Uncorrected and PCR-corrected efficacy results at day 28 were calculated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Totals of 368 and 273 patients were enrolled in the AL and AS\u2013AQ arms, respectively. Of these, 9.5% (35\/368) and 5.1% (14\/273) were lost to follow-up in the AL and AS\u2013AQ arms, respectively. There were 48 and 3 recurrent malaria infections (late clinical and late parasitological failures) in the AL and AS\u2013AQ arms, respectively. The day 28 uncorrected efficacy was 85.6% (95% confidence interval (CI) 81.3\u201389.2%) for AL and 98.8% (95% CI 96.7\u201399.8%) for AS\u2013AQ, whereas day 28 PCR-corrected efficacy was 97.9% (95% CI 95.6\u201399.2%) for AL and 99.6% (95% CI 97.9\u2013100%) for AS\u2013AQ. Molecular testing confirmed that 87.4% (42\/48) and 33.3% (1\/3) of participants with a recurrent malaria infection in the AL and AS\u2013AQ arms were new infections; an expected finding in a high malaria transmission area. Adverse events were documented in less than 2% of participants for both drugs.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Both AL and AS\u2013AQ have therapeutic efficacies well above the 90% WHO recommended threshold and remain well-tolerated in Mozambique. Routine monitoring of therapeutic efficacy should continue to ensure the treatments remain efficacious.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> Clinicaltrials.gov: NCT04370977<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12936-021-03922-9","type":"journal-article","created":{"date-parts":[[2021,10,4]],"date-time":"2021-10-04T14:45:42Z","timestamp":1633358742000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["In vivo efficacy and safety of artemether\u2013lumefantrine and amodiaquine\u2013artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018"],"prefix":"10.1186","volume":"20","clinical-trial-number":[{"clinical-trial-number":"nct04370977","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Abel","family":"Nhama","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L\u00eddia","family":"Nham\u00fassua","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eus\u00e9bio","family":"Macete","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quique","family":"Bassat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Crizolgo","family":"Salvador","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00f3nia","family":"Enosse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baltazar","family":"Candrinho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Carvalho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ars\u00e9nio","family":"Nhacolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arlindo","family":"Chidimatembue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abuchahama","family":"Saifodine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rose","family":"Zulliger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomi","family":"Lucchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samaly S.","family":"Svigel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leah F.","family":"Moriarty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric S.","family":"Halsey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfredo","family":"Mayor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2379-6529","authenticated-orcid":false,"given":"Pedro","family":"Aide","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,10,2]]},"reference":[{"key":"3922_CR1","unstructured":"WHO. 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Before enrollment, written informed consent was obtained from the children\u2019s parents or legal guardians.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Authors have no competing interests to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"390"}}