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

Abstract

The therapeutic efficacy and effects of artemether-lumefantrine (AL) and artesunate-amodiaquine co-formulated (AAcf) or co-packaged (AAcp) on malaria-associated anemia (MAA) were evaluated in 285 children < 12 years of age with uncomplicated Plasmodium falciparum malaria randomized to receive one of the three drug combinations. Fever and parasite clearance times were similar in all treatment groups. Mean drug-attributable fall in hematocrit (DAFH), defined as difference between hematocrit values pre- and 3 d post- initiation of treatment, was low (< 4.5%) and rates of recovery from MAA were similar with all treatments. Mean areas under curve (AUCs) of the plot of deficit in hematocrit levels from 30% versus time in anemic children were similar in all groups. All regimens were well tolerated. AL, AAcf and AAcp cleared fever and parasitemia rapidly and had similar rates of resolution of MAA after treatment in malarious Nigerian children.

Therapeutic Efficacies of Artemisinin-Based Combination Therapies in Nigerian Children with Uncomplicated Falciparum Malaria during Five Years of Adoption as First-Line Treatments

“…The drug combinations were generally well-tolerated, and no patient reported having serious adverse events. [12][13][14][15][16] Three patients deteriorated within 2 hours of starting AA ( N = 2) or AL ( N = 1), becoming cerebral and requiring hospital admission. All recovered uneventfully.…”

“…Specific study procedures have been described for each trial. [12][13][14][15][16] In addition, one recently controlled completed but unpublished trial has been included in the analysis. This involved comparison of AL and AA in < 5 year olds.…”

“…Response to drug treatment was assessed using World Health Organization (WHO) 1973 and 2003 criteria 4, 5 as previously described. [12][13][14][15][16] Parasite clearance time was defined as time from drug administration until there was no patent parasitemia for at least 48 hours. Fever clearance time was defined as time from drug administration until body temperature fell to or below 37.4°C and remained below this value for at least 48 hours.…”

“…[12][13][14][15] Capillary blood collected before and during follow-up was used to measure packed cell volume (PCV) or hematocrit. Hematocrits were measured using a microhematocrit tube and microcentrifuge (Hawksley, Lancing, United Kingdom).…”

Efficacy and safety of Camosunate for the treatment of uncomplicated malaria in the University of Benin Teaching Hospital, Benin City, Nigeria

“…A smear was declared negative when the examination of 100 thick-film fields did not reveal the presence of malaria parasites. 13 Quality control checks were performed on a random 10% sample of blood films, examined at an independent site. Four age strata, based on the formulations of Camosunate by the manufacturers were identified prior to the study.…”