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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
A randomized trial on effectiveness of artemether-lumefantrine versus artesunate plus amodiaquine for unsupervised treatment of uncomplicated Plasmodium falciparum malaria in Ghanaian children
Malaria Journal, Volume 7, Article 261, Year 2008
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Description
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. © 2008 Kobbe et al; licensee BioMed Central Ltd.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2625364/bin/1475-2875-7-261-S1.doc
Authors & Co-Authors
Kobbe, Robin
Unknown Affiliation
Klein, Philipp
Unknown Affiliation
Adjei, Samuel
Unknown Affiliation
Amemasor, Solomon
Unknown Affiliation
Thompson, William N.A.
Unknown Affiliation
Heidemann, Hanna
Unknown Affiliation
Nielsen, Maja Verena
Unknown Affiliation
Vohwinkel, Julia
Unknown Affiliation
Hogan, Benedikt
Unknown Affiliation
Kreuels, Benno
Unknown Affiliation
Bührlen, Martina
Unknown Affiliation
Loag, Wibke
Unknown Affiliation
Ansong, Daniel Ayirebi
Unknown Affiliation
May, Juergen ü.
Unknown Affiliation
Statistics
Citations: 43
Authors: 14
Affiliations: 7
Identifiers
Doi:
10.1186/1475-2875-7-261
e-ISSN:
14752875
Research Areas
Environmental
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study
Study Locations
Ghana