Effectiveness and safety of artesunate-amodiaquine versus artemether-lumefantrine for home-based treatment of uncomplicated Plasmodium falciparum malaria among children 6-120 months in Yaoundé, Cameroon: a randomized trial.
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Niba Peter Thelma Ngwa, Nji Akindeh Mbuh, Ali Innocent Mbulli, Akam Lawrence Fonyonga, Dongmo Cedric Hermann, Chedjou Jean Paul Kengne, Fomboh Calvino Tah, Nana William Dorian, Oben Ornella Laetitia Ayem, Selly-Ngaloumo Abdel Aziz, Moyeh Marcel N, Ngu Jude Achidi, Ludovic Ambassa Jean, Aboh Pierre Martiniel, Ambani Marie Carine Enyegue, Omgba Pierrette Albertine Mbarga, Kotcholi Grâce Bissohong, Adzemye Linus Moye, Nna Danielle Regine Abenkou, Douanla Adèle, Ango Ze, Ewane Marie Sophie, Ticha Joel Tewara, Tatah Fritz Mbuh, Dinza Golwa, Ndikum Valentine Nchafor, Fosah Dorothy A, Bigoga Jude D, Alifrangis Michael, Mbacham Wilfred F
Аннотация
METHODS: A two-arm, open-label, randomized, controlled trial comparing the equivalence of AS-AQ (experimental group) and AL (control group) was carried out from May 2019 to April 2020 at two secondary hospitals in Yaoundé. Participants were randomized to receive either AS-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-treatment and post-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-treatment. Safety was based on assessment of adverse events (AEs) and severe adverse events (SAEs) from day 1 to day 28.
RESULTS: A total of 242 children were randomized to receive AS-AQ (n = 114) and AL (n = 128). The PP PCR adjusted day 28 cure rates were [AS-AQ = 96.9% (95% CI, 91.2-99.4) versus AL = 95.5% (95% CI, 89.9-98.5), P = 0.797]. Expected mild to moderate adverse events were reported in both arms [AS-AQ = 83 (84.7%) versus AL = 99 (86.1%), P = 0.774]. The most common adverse events included: transient changes of hematologic indices and fever.
CONCLUSIONS: This study demonstrated that AS-AQ and AL are effective and safe for home management of malaria in Yaoundé. 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.
TRIAL REGISTRATION: This study is a randomized controlled trial and it was retrospectively registered on 23/09/2020 at ClinicalTrials.gov with registration number NCT04565184.