TY - JOUR

T1 - 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

T2 - a randomized trial

AU - Niba, Peter Thelma Ngwa

AU - Nji, Akindeh Mbuh

AU - Ali, Innocent Mbulli

AU - Akam, Lawrence Fonyonga

AU - Dongmo, Cedric Hermann

AU - Chedjou, Jean Paul Kengne

AU - Fomboh, Calvino Tah

AU - Nana, William Dorian

AU - Oben, Ornella Laetitia Ayem

AU - Selly-Ngaloumo, Abdel Aziz

AU - Moyeh, Marcel N.

AU - Ngu, Jude Achidi

AU - Ludovic, Ambassa Jean

AU - Aboh, Pierre Martiniel

AU - Ambani, Marie Carine Enyegue

AU - Omgba, Pierrette Albertine Mbarga

AU - Kotcholi, Grâce Bissohong

AU - Adzemye, Linus Moye

AU - Nna, Danielle Regine Abenkou

AU - Douanla, Adèle

AU - Ango, Ze

AU - Ewane, Marie Sophie

AU - Ticha, Joel Tewara

AU - Tatah, Fritz Mbuh

AU - Dinza, Golwa

AU - Ndikum, Valentine Nchafor

AU - Fosah, Dorothy A.

AU - Bigoga, Jude D.

AU - Alifrangis, Michael

AU - Mbacham, Wilfred F.

N1 - Publisher Copyright: © 2022, The Author(s).

PY - 2022

Y1 - 2022

N2 - Background: Many studies have reported high efficacy and safety of artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) when administered under direct observation in Cameroon. There is paucity of data to support their continuous use in home-based treatment of uncomplicated Plasmodium falciparum malaria in Cameroon. Hence, this study aimed to assess the effectiveness and safety of AS-AQ versus AL for home-based treatment of uncomplicated P. falciparum malaria among children 6–120 months in Yaoundé, Cameroon. 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.

AB - Background: Many studies have reported high efficacy and safety of artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) when administered under direct observation in Cameroon. There is paucity of data to support their continuous use in home-based treatment of uncomplicated Plasmodium falciparum malaria in Cameroon. Hence, this study aimed to assess the effectiveness and safety of AS-AQ versus AL for home-based treatment of uncomplicated P. falciparum malaria among children 6–120 months in Yaoundé, Cameroon. 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.

KW - Artemether-lumefantrine

KW - Artesunate-amodiaquine

KW - Cameroon

KW - Effectiveness

KW - Malaria

KW - Plasmodium falciparum

KW - Safety

U2 - 10.1186/s12879-022-07101-2

DO - 10.1186/s12879-022-07101-2

M3 - Journal article

C2 - 35189818

AN - SCOPUS:85125004734

VL - 22

JO - B M C Infectious Diseases

JF - B M C Infectious Diseases

SN - 1471-2334

M1 - 166

ER -