{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T13:25:07Z","timestamp":1790601907682,"version":"4.1.0"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T00:00:00Z","timestamp":1715558400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T00:00:00Z","timestamp":1715558400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100019778","name":"U.S. President\u2019s Malaria Initiative","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100019778","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Malar J"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Monitoring therapeutic efficacy is important to ensure the efficacy of artemisinin-based combination therapy (ACT) for malaria. The current first-line treatment for uncomplicated malaria recommended by the National Malaria Control Program in Niger is artemether\u2013lumefantrine (AL). In 2020, an in vivo study was carried out to evaluate clinical and parasitological responses to AL as well as the molecular resistance to the drug in three sentinel sites: Agadez, Tessaoua and Gaya, in Niger.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A multi-center, single-arm trial was conducted according to the 28-day World Health Organization (WHO) 2009 therapeutic efficacy study protocol. Children between 6\u00a0months and 15\u00a0years with confirmed uncomplicated\n                      <jats:italic>Plasmodium falciparum<\/jats:italic>\n                      infection and 1000\u2013200,000 asexual parasites\/\u03bcL of blood were enrolled and followed up for 28\u00a0days. Uncorrected and PCR-corrected efficacy results at day 28 were calculated, and molecular correction was performed by genotyping the\n                      <jats:italic>msp1, msp2,<\/jats:italic>\n                      and\n                      <jats:italic>glurp<\/jats:italic>\n                      genes. The\n                      <jats:italic>pfk13, pfdhfr, pfdhps, pfcrt and pfmdr<\/jats:italic>\n                      genes were analyzed by PCR and Sanger sequencing. The Kaplan\u2013Meier curve assessed parasite clearance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 255 patients were enrolled in the study. The adequate clinical and parasitological response after PCR correction was 98.9% (95% CI 96.4\u2013101.0%), 92.2% (85.0\u201398.5%) and 97.1% (93.1\u2013101.0%) in Gaya, Tessaoua and Agadez, respectively. No adverse events were observed. Ten mutations (SNP) were found, including 7 synonyms (K248K, G690G, E691E, E612E, C469C, G496G, P718P) and 3 non-synonyms (N594K, R255K, V714S). Two mutations emerged: N594K and V714S. The R255K mutation detected in Southeast Asia was also detected. The\n                      <jats:italic>pfdhpsK540E and pfdhfrI164L<\/jats:italic>\n                      mutations associated with high levels of resistance are absent. There is a reversal of chloroquine resistance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The study findings indicate that AL is effective and well tolerated for the treatment of uncomplicated malaria in three sites in Niger. The emergence of a\n                      <jats:italic>pfk13<\/jats:italic>\n                      mutation requires additional testing such as the Ring Stage Assay and CRISPR\/Cas9 to confirm the role of these emerging mutations.\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:italic>Trial registration<\/jats:italic>\n                      NCT05070520, October 7, 2021.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12936-024-04945-8","type":"journal-article","created":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T17:01:44Z","timestamp":1715619704000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Therapeutic efficacy and tolerability of artemether\u2013lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020"],"prefix":"10.1186","volume":"23","clinical-trial-number":[{"clinical-trial-number":"nct05070520","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ibrahim M.","family":"Laminou","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahima","family":"Issa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Adehossi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kabirou","family":"Maman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadiza","family":"Jackou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Coulibaly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zilahatou B.","family":"Tohon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jehan","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisha","family":"Sanoussi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Koko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,5,13]]},"reference":[{"key":"4945_CR1","volume-title":"Plan strat\u00e9gique de lutte contre le paludisme au Niger 2017\u20132021","author":"MSP-PNLP","year":"2016","unstructured":"MSP-PNLP. 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The Population Services International Research Ethics Committee determined that the activity was public health surveillance. All patients enrolled in the study provided their free and informed consent. For minors, informed consent was obtained from the patient\u2019s parent or legal guardian. The consent forms were dated and signed by both parties. The data collected was kept anonymous and confidential.","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":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"144"}}