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Randomized Controlled Trial
. 2007 May 22:6:65.
doi: 10.1186/1475-2875-6-65.

Randomized clinical trial of artemisinin versus non-artemisinin combination therapy for uncomplicated falciparum malaria in Madagascar

Didier Ménard  1 , Nohary Nina Harimanana Andrianina, Zakaherizo Ramiandrasoa, Arthur Randriamanantena, Noéline Rasoarilalao, Martial Jahevitra, Arsène Ratsimbasoa, Luciano Tuseo, Andrianirina Raveloson
Affiliations
Randomized Controlled Trial

Randomized clinical trial of artemisinin versus non-artemisinin combination therapy for uncomplicated falciparum malaria in Madagascar

Didier Ménard et al. Malar J. .

Abstract

Background: Data concerning antimalarial combination treatment for uncomplicated malaria in Madagascar are largely lacking. Randomized clinical trial was designed to assess therapeutic efficacies of chloroquine (CQ), amodiaquine (AQ), sulphadoxine-pyrimethamine (SP), amodiaquine plus sulphadoxine-pyrimethamine combination (AQ+SP) and artesunate plus amodiaquine combination (AQ+AS).

Methods: 287 children between 6 months and 15 years of age, with uncomplicated falciparum malaria, were enrolled in the study. Primary endpoints were the day-14 and day-28 risks of parasitological failure, either unadjusted or adjusted by genotyping.

Results: All treatment regimens, except for CQ treatment, gave clinical cure rates above 97% by day-14 and 92% by day-28 (PCR-corrected). AQ+SP was as effective as AQ+AS. The risk of new infection within the month after therapy was generally higher for AQ+AS than AQ+SP.

Conclusion: These findings show that the inexpensive and widely available combination AQ+SP may be valuable in for the treatment of uncomplicated malaria in Madagascar and could have an important role in this country, where much of the drugs administered go to patients who do not have malaria.

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Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Proportions of febrile patients following treatment. CQ, Chloroquine, AQ, Amodiaquine; SP, Sulfadoxine-Pyrimethamine; AS, artesunate; On day 1, Significant difference to SP group (P < 0.05), SP vs. AQ+SP, SP vs. AQ+AS; At day 2, Significant difference to SP group (P < 0.05), SP vs. AQ+AS; On day 14, Significant difference to CQ group (P < 0.05), CQ vs. AQ, CQ vs. SP, CQ vs. AQ+SP, CQ vs. AQ+AS
Figure 3
Figure 3
Proportions of parasitaemic patients following treatment. CQ, Chloroquine, AQ, Amodiaquine; SP, Sulfadoxine-Pyrimethamine; AS, artesunate; On day 1, Significant difference to CQ group (P < 0.05), CQ vs. SP, CQ vs. AQ+AS; Significant difference to AQ group (P < 0.05), AQ vs. AQ+AS; Significant difference to AQ+SP group (P < 0.05), AQ+SP vs. AQ+AS; On day 2, Significant difference to SP group (P < 0.05), SP vs. CQ; Significant difference to AQ+AS group (P < 0.05), AQ+AS vs. CQ, AQ+AS vs. AQ, AQ+AS vs. SP, AQ+AS vs. AQ+SP; on day 14, Significant difference to CQ group (P < 0.05), CQ vs. AQ, CQ vs. SP, CQ vs. AQ+SP, CQ vs. AQ+AS; On day 21, Significant difference to CQ group (P < 0.05), CQ vs. AQ, CQ vs. AQ+SP, CQ vs. AQ+AS; On day 28, Significant difference to AQ+SP group (P < 0.05), AQ+SP vs. AQ+AS
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