Safety of the methylene blue plus chloroquine combination in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso ISRCTN27290841Reportar como inadecuado




Safety of the methylene blue plus chloroquine combination in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso ISRCTN27290841 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Malaria Journal

, 4:45

First Online: 22 September 2005Received: 07 July 2005Accepted: 22 September 2005

Abstract

BackgroundSafe, effective and affordable drug combinations against falciparum malaria are urgently needed for the poor populations in malaria endemic countries. Methylene blue MB combined with chloroquine CQ has been considered as one promising new regimen.

ObjectivesThe primary objective of this study was to evaluate the safety of CQ-MB in African children with uncomplicated falciparum malaria. Secondary objectives were to assess the efficacy and the acceptance of CQ-MB in a rural population of West Africa.

MethodsIn this hospital-based randomized controlled trial, 226 children 6–59 months with uncomplicated falciparum malaria were treated in Burkina Faso. The children were 4:1 randomized to CQ-MB n = 181; 25 mg-kg CQ and 12 mg-kg MB over three days or CQ n = 45; 25 mg-kg over three days respectively. The primary outcome was the incidence of severe haemolysis or other serious adverse events SAEs. Efficacy outcomes were defined according to the WHO 2003 classification system. Patients were hospitalized for four days and followed up until day 14.

ResultsNo differences in the incidence of SAEs and other adverse events were observed between children treated with CQ-MB including 24 cases of G6PD deficiency compared to children treated with CQ. There was no case of severe haemolysis and also no significant difference in mean haemoglobin between study groups. Treatment failure rates were 53.7% 95% CI 37.4%; 69.3% in the CQ group compared to 44.0% 95% CI 36.3%; 51.9% in the CQ-MB group.

ConclusionMB is safe for the treatment of uncomplicated falciparum malaria, even in G6PD deficient African children. However, the efficacy of the CQ-MB combination has not been sufficient at the MB dose used in this study. Future studies need to assess the efficacy of MB at higher doses and in combination with appropriate partner drugs.

Electronic supplementary materialThe online version of this article doi:10.1186-1475-2875-4-45 contains supplementary material, which is available to authorized users.

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Autor: Peter E Meissner - Germain Mandi - Steffen Witte - Boubacar Coulibaly - Ulrich Mansmann - Jens Rengelshausen - Wolfgang Sc

Fuente: https://link.springer.com/







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