Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria

Abstract

Background: The use of artemisinin derivative-based combination therapy (ACT) such as artesunate plus amodiaquine is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. Fixed-dose combinations are more adapted to patients than regimens involving multiple tablets and improve treatment compliance. A fixed-dose combination of artesunate + amodiaquine (ASAQ) was recently developed. To assess the efficacy and safety of this new combination and to define its optimum dosage regimen (once or twice daily) in the treatment of uncomplicated P. falciparum malaria, a multicentre clinical study was conducted.

Therapeutic Efficacy and Effects of Artemether-Lumefantrine and Artesunate-Amodiaquine Coformulated or Copackaged on Malaria-Associated Anemia in Children with Uncomplicated Plasmodium falciparum Malaria in Southwest Nigeria

“…12 Prompt fever and parasite clearance times by both AL and the formulations of AA are in agreement with findings from Africa and elsewhere. 5,6,8,12,23 Gametocyte carriage at enrolment in the cohort of children evaluated (3%) was lower than in previous studies from the same area during the use of monotherapies (10-12%). 24 ACTs have been used consistently in children from the study community in the last 5 years and may have been responsible for the relatively low gametocyte carriage compared with the pre-ACT use period.…”

“…A recent study in five African countries has shown that fixed-dose AA is as efficacious as AL in children. 8 However, there are few or no recent studies comparing fixed-dose and copackaged AA with AL in malarious African children. It is, therefore, necessary to evaluate whether AAcf or AAcp is biologically and therapeutically equivalent in malarious children in endemic areas, because cost and effectiveness are issues that may militate against reduction of morbidity and mortality in these areas.…”

Polymorphism of the Merozoite Surface Protein-1 Block 2 Region in Plasmodium Falciparum Isolates from Symptomatic Individual Living in Rural Area of Senegal

“…Our findings are supported by similar study conducted in Burkina Faso where authors found that msp1_Mad20 allelic family was less frequent in infected children from rural area than those from urban area [23]. highly effectives with an adequate clinical and parasitological cure rate over 95% [24]. As any drug, ACT could result in genetic modification of the P. falciparum parasites.…”

In Vivo Efficacy and Parasite Clearance of Artesunate + Sulfadoxine–Pyrimethamine Versus Artemether–Lumefantrine in Mali

“…The sample size was calculated using a non-inferiority hypothesis of AS+SP versus AL, which had an efficacy rate of 95%. 18 A non-inferiority range of 5%, an alpha risk of 5%, a power of 80%, and lost to follow-up of 10% were assumed to yield a total sample size of 503 subjects. Volunteers were recruited by applying a simple random sampling among patients visiting our medical teams during the study periods.…”