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There is paucity of data to support their continuous use in home\n                      <jats:bold>-<\/jats:bold>\n                      based treatment of uncomplicated\n                      <jats:italic>Plasmodium falciparum<\/jats:italic>\n                      malaria in Cameroon.\u00a0Hence, this study aimed to assess the effectiveness and safety of AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ versus AL for home\n                      <jats:bold>-<\/jats:bold>\n                      based treatment of uncomplicated\n                      <jats:italic>P<\/jats:italic>\n                      .\n                      <jats:italic>falciparum<\/jats:italic>\n                      malaria among children 6\n                      <jats:bold>\u2013<\/jats:bold>\n                      120\u00a0months in Yaound\u00e9, Cameroon.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A two\n                      <jats:bold>-<\/jats:bold>\n                      arm, open\n                      <jats:bold>-<\/jats:bold>\n                      label, randomized, controlled trial comparing the equivalence of AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ (experimental group) and AL (control group) was carried out from May 2019 to April 2020 at two secondary hospitals in Yaound\u00e9. Participants were randomized to receive either AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ or AL. After the first dose, antimalarial drugs were given at home, rather than under direct observation by a study staff. The conventional on\n                      <jats:bold>-<\/jats:bold>\n                      treatment and post\n                      <jats:bold>-<\/jats:bold>\n                      treatment laboratory and clinical evaluations were not done until day 3 of the full antimalarial treatment course. The evaluation of effectiveness was mainly based on per protocol polymerase chain reaction adjusted adequate clinical and parasitological response (PP PCR adjusted ACPR) on day 28 post\n                      <jats:bold>-<\/jats:bold>\n                      treatment. Safety was based on assessment of adverse events (AEs) and severe adverse events (SAEs) from day 1 to day 28.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 242 children were randomized to receive AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ (n\u2009=\u2009114) and AL (n\u2009=\u2009128). The PP PCR adjusted day 28 cure rates were [AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ\u2009=\u200996.9% (95% CI, 91.2\n                      <jats:bold>\u2013<\/jats:bold>\n                      99.4) versus AL\u2009=\u200995.5% (95% CI, 89.9\n                      <jats:bold>\u2013<\/jats:bold>\n                      98.5), P\u2009=\u20090.797]. Expected mild to moderate adverse events were reported in both arms [AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ\u2009=\u200983 (84.7%) versus AL\u2009=\u200999 (86.1%), P\u2009=\u20090.774]. The most common adverse events included: transient changes of hematologic indices and fever.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      This study demonstrated that AS\n                      <jats:bold>-<\/jats:bold>\n                      AQ and AL are effective and safe for home management of malaria in Yaound\u00e9. The evidence from this study supports the parallel use of the two drugs in routine practice. However, the findings from this study do not describe the likely duration of antimalarial effectiveness in holoendemic areas where multiple courses of treatment might be required.\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:italic>Trial registration:<\/jats:italic>\n                      This study is a randomized controlled trial and it was retrospectively registered on 23\/09\/2020 at ClinicalTrials.gov with registration number NCT04565184.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12879-022-07101-2","type":"journal-article","created":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T13:10:51Z","timestamp":1645449051000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Effectiveness and safety of artesunate\u2013amodiaquine versus artemether\u2013lumefantrine for home-based treatment of uncomplicated Plasmodium 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Administrative authorizations were also sought from the Director of District Hospital Cit\u00e9 Verte, Director of District Medical Center Minkoa<b>-<\/b>Meyos, Center Regional Delegate of Public Health and the Minister of Public Health. In addition, the study was explained using the participant information sheet (PIS) and written assent in French or English was duly obtained from the parents\/guardians of each participant before enrolment and collection of samples.","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":"166"}}