Abstract

BackgroundThe present paper reports on studies that evaluated artesunate + sulfadoxine-pyrimethamine (AS + SP) which is the first-line drug and artemether-lumefantrine (AL) which is a second-line drug against uncomplicated falciparum malaria in Sudan. This evaluation was performed in twenty studies covering six sentinel sites during five successive annual malaria transmission seasons from 2010 to 2015.MethodsThe standard World Health Organization protocol was used for a follow-up period of 28 days. The frequency distribution of molecular markers for antifolate resistance in dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) genes was studied in pre-treatment samples in four sites in 2011.ResultsIn the nine studies of AL conducted at five sites (n = 595), high PCR-corrected cure rates were found, ranging from 96.8 to 100 %. Among the eleven studies of AS + SP (n = 1013), a decline in the PCR-corrected cure rates was observed in Gedaref in Eastern Sudan: 91.0 % in the 2011–12 season and 86.5 % in the 2014–15 season. In the remaining sites, the AS + SP cure rates ranged between 95.6 and 100 %. The rate of clearance of microscopic gametocytaemia after treatment was not significantly different with AL or AS + SP on days 7, 14, 21 and 28 of follow-up. A total of 371 pre-treatment samples were analysed for molecular markers of SP resistance. The temporal changes and geographical differences in the frequency distribution of SP-resistance genotypes showed evidence of regional differentiation and selection of resistant strains.ConclusionThe findings of this study call for a need to review the Sudan malaria treatment policy. Epidemiological factors could play a major role in the emergence of drug-resistant malaria in eastern Sudan.Australian New Zealand Clinical Trials RegistryTrial registration numbers 2011–2012: ACTRN12611001253998, 2013–2015: ACTRN12613000945729

Highlights

  • The present paper reports on studies that evaluated artesunate + sulfadoxine-pyrimethamine (AS + SP) which is the first-line drug and artemether-lumefantrine (AL) which is a second-line drug against uncompli‐ cated falciparum malaria in Sudan

  • Around the time when AS + SP was adopted as the first-line treatment for falciparum malaria, a number of therapeutic efficacy studies evaluated SP in Sudan, either as a monotherapy or in combination with other antimalarials [3]

  • This paper reports the results of therapeutic efficacy studies on AL and AS + SP conducted in Sudan from 2010 to 2015

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Summary

Introduction

The present paper reports on studies that evaluated artesunate + sulfadoxine-pyrimethamine (AS + SP) which is the first-line drug and artemether-lumefantrine (AL) which is a second-line drug against uncompli‐ cated falciparum malaria in Sudan. This evaluation was performed in twenty studies covering six sentinel sites during five successive annual malaria transmission seasons from 2010 to 2015. Around the time when AS + SP was adopted as the first-line treatment for falciparum malaria, a number of therapeutic efficacy studies evaluated SP in Sudan, either as a monotherapy or in combination with other antimalarials [3]. An analysis of molecular markers conferring resistance to SP resistance is provided for four sentinel sites studied in 2011

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