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Randomized Controlled Trial
. 2008 Dec 19:7:261.
doi: 10.1186/1475-2875-7-261.

A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children

Robin Kobbe  1 , Philipp Klein, Samuel Adjei, Solomon Amemasor, William Nana Thompson, Hanna Heidemann, Maja V Nielsen, Julia Vohwinkel, Benedikt Hogan, Benno Kreuels, Martina Bührlen, Wibke Loag, Daniel Ansong, Jürgen May
Affiliations
Randomized Controlled Trial

A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children

Robin Kobbe et al. Malar J. .

Abstract

Background: Numerous trials have demonstrated high efficacy and safety of artemisinin-based combination therapy (ACT) under supervised treatment. In contrast, effectiveness studies comparing different types of ACT applied unsupervised are scarce. The aim of this study was to compare effectiveness, tolerability and acceptance of artesunate plus amodiaquine (ASAQ) against that of artemether-lumefantrine (AL) in Ghanaian children with uncomplicated Plasmodium falciparum malaria.

Methods: A randomized open-label trial was conducted at two district hospitals in the Ashanti region, Ghana, an area of intense malaria transmission. A total of 246 children under five years of age were randomly assigned to either ASAQ (Arsucam) or AL (Coartem). Study participants received their first weight-adjusted dose under supervision. After the parent/guardian was advised of times and mode of administration the respective three-day treatment course was completed unobserved at home. Follow-up visits were performed on days 3, 7, 14 and 28 to evaluate clinical and parasitological outcomes, adverse events, and haematological recovery. Length polymorphisms of variable regions of msp1 and msp2 were determined to differentiate recrudescences from reinfections. Acceptance levels of both treatment regimens were assessed by means of standardized interviews.

Results: Adequate clinical and parasitological responses after AL and ASAQ treatment were similar (88.3% and 91.7%, respectively). Interestingly, more late clinical failures until day 28 occurred in AL-treated children than in those who received ASAQ (17.5% and 7.3%, respectively; Hazard Ratio 2.41, 95% CI 1.00-5.79, p < 0.05).Haematological recovery and drug tolerability were not found to be significantly different in both study arms. The acceptance of treatment with ASAQ was higher than that with AL (rank-scores 10.6 and 10.3, respectively; p < 0.05).

Conclusion: Unobserved AL and ASAQ treatment showed high adequate clinical and parasitological responses, though AL was inferior in preventing late clinical failures.

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Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Kaplan-Meier survival curve of adequate clinical and parasitological response (ACPR). The figure shows the percentage of children with ACPR during the follow-up time of 28 days (in some plus 1 day) separated by treatment group according to the per-protocol analysis. The red line indicates children treated with artemether-lumefantrine (AL), the blue line indicates children treated with artesunate plus amodiaquine (ASAQ).
Figure 3
Figure 3
Kaplan-Meier failure curve of late clinical failures (LCF). The figure shows the percentage of children with LCF during the follow-up time of 28 days (in some plus 1 day) separated by treatment group according to the per-protocol analysis. The red line indicates children treated with artemether-lumefantrine (AL), the blue line indicates children treated with artesunate plus amodiaquine (ASAQ).
See this image and copyright information in PMC

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