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A comparison of the efficacy of artesunate plus sulfadoxine-pyrimethamine with that of sulfadoxine-pyrimethamine alone, in the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan

In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Pati...

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Published in:Annals of tropical medicine and parasitology 2005-07, Vol.99 (5), p.449-455
Main Authors: Adam, I., A-Elbasit, I. E., Idris, S. M., Malik, E. M., Elbashir, M. I.
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description In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg. day) on days 0-2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. Compared with the 30 given artesunate plus SP (ASP), the 30 given SP alone were much more likely to be febrile (30% v. 3.3%; P=0.006) and parasitaemic (50% v. 6.7%; P
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E. ; Idris, S. M. ; Malik, E. M. ; Elbashir, M. I.</creator><creatorcontrib>Adam, I. ; A-Elbasit, I. E. ; Idris, S. M. ; Malik, E. M. ; Elbashir, M. I.</creatorcontrib><description>In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg. day) on days 0-2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. Compared with the 30 given artesunate plus SP (ASP), the 30 given SP alone were much more likely to be febrile (30% v. 3.3%; P=0.006) and parasitaemic (50% v. 6.7%; P&lt;00001) on day 1. By day 3, 16.7% of the patients given SP alone were still febrile and 6.7% of them were still parasitaemic, although all the patients given ASP were then afebrile (P=0.02) and aparasitaemic (P=0.1). Five (16.7%) of the patients treated with SP alone but none of those given ASP appeared to be treatment failures (P&lt;0.05). Parasite genotyping revealed that four of the five apparent treatment failures were true recrudescences but the other represented a re-infection detected on day 28. The true frequencies of cure by day 28 were therefore 100% for ASP and 86.7% for SP alone (P=0.02). Adverse effects of treatment (nausea, itching and giddiness) were observed with similar frequencies in the two treatment arms (10.0% of the patients given ASP v. 13.3% of the patients given SP alone; P&gt;0.05). The frequencies of gametocytaemia during follow-up were, however, much lower in the ASP arm than in the SP-only (0.0% v. 23.3%; P=0.005). 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E.</creatorcontrib><creatorcontrib>Idris, S. M.</creatorcontrib><creatorcontrib>Malik, E. M.</creatorcontrib><creatorcontrib>Elbashir, M. I.</creatorcontrib><title>A comparison of the efficacy of artesunate plus sulfadoxine-pyrimethamine with that of sulfadoxine-pyrimethamine alone, in the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan</title><title>Annals of tropical medicine and parasitology</title><addtitle>Ann Trop Med Parasitol</addtitle><description>In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg. day) on days 0-2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. 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The frequencies of gametocytaemia during follow-up were, however, much lower in the ASP arm than in the SP-only (0.0% v. 23.3%; P=0.005). Thus, although the problems posed by adverse effects were similar in the two treatment arms, ASP appeared markedly better, in terms of fever- and parasite-clearance times and the prevalence of post-treatment gametocytaemia, than SP alone.</description><subject>Adolescent</subject><subject>Antimalarials - adverse effects</subject><subject>Antimalarials - therapeutic use</subject><subject>Artemisinins - adverse effects</subject><subject>Artemisinins - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Drug Combinations</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>General aspects</subject><subject>Human protozoal diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Malaria</subject><subject>Malaria, Falciparum - drug therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Parasitemia - drug therapy</subject><subject>Parasitic diseases</subject><subject>Plasmodium falciparum</subject><subject>Protozoal diseases</subject><subject>Pyrimethamine - adverse effects</subject><subject>Pyrimethamine - therapeutic use</subject><subject>Recurrence</subject><subject>Sesquiterpenes - adverse effects</subject><subject>Sesquiterpenes - therapeutic use</subject><subject>Sudan</subject><subject>Sulfadoxine - adverse effects</subject><subject>Sulfadoxine - therapeutic use</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><issn>0003-4983</issn><issn>1364-8594</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><recordid>eNp1kV1rFTEQhoMo9rR67Z3kRq-6bbKb_fKuFK1CQUEF75bZ7IQTyceaZGnPT-y_MttzxFLoVTLD877zMkPIG87OOG_7c141oqt7Vv-qmrLvn5HN2ilySzwnG8ZYVYi-q47IcYy_c1k2TLwkR7xhTLRMbMjdBZXezhB09I56RdMWKSqlJcjdWkNIGBcHCelslkjjYhRM_lY7LOZd0BbTFmyu6I1O2yyHtMqexsB4h6dUu_tRKSAki-5etLg1i8mzE06n9JuBaP2kF0sVGKlzyvy1YHJaWA0QYsLg6PdlAveKvMhUxNeH94T8_PTxx-Xn4vrr1ZfLi-tCCtamAqVipWqFbLhoS85Z0wKwFlldd2M3jqKGkrejgIoLwTtedh02wLuSVWqapq46Ie_3vnPwfxaMabA6SjQGHPolDrxl2Zc1GTzfgzL4GAOqYc57gLAbOBvW6w2PrpcVbw_Wy2hx-s8fzpWBdwcAogSjAjip4wOuF1XP19Ef9px2ygcLNz6YaUiwMz78E1VPpfgL0tq5dg</recordid><startdate>20050701</startdate><enddate>20050701</enddate><creator>Adam, I.</creator><creator>A-Elbasit, I. 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E.</creatorcontrib><creatorcontrib>Idris, S. M.</creatorcontrib><creatorcontrib>Malik, E. M.</creatorcontrib><creatorcontrib>Elbashir, M. I.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Annals of tropical medicine and parasitology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Adam, I.</au><au>A-Elbasit, I. E.</au><au>Idris, S. M.</au><au>Malik, E. M.</au><au>Elbashir, M. I.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A comparison of the efficacy of artesunate plus sulfadoxine-pyrimethamine with that of sulfadoxine-pyrimethamine alone, in the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan</atitle><jtitle>Annals of tropical medicine and parasitology</jtitle><addtitle>Ann Trop Med Parasitol</addtitle><date>2005-07-01</date><risdate>2005</risdate><volume>99</volume><issue>5</issue><spage>449</spage><epage>455</epage><pages>449-455</pages><issn>0003-4983</issn><eissn>1364-8594</eissn><coden>ATMPA2</coden><abstract>In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg. day) on days 0-2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. Compared with the 30 given artesunate plus SP (ASP), the 30 given SP alone were much more likely to be febrile (30% v. 3.3%; P=0.006) and parasitaemic (50% v. 6.7%; P&lt;00001) on day 1. By day 3, 16.7% of the patients given SP alone were still febrile and 6.7% of them were still parasitaemic, although all the patients given ASP were then afebrile (P=0.02) and aparasitaemic (P=0.1). Five (16.7%) of the patients treated with SP alone but none of those given ASP appeared to be treatment failures (P&lt;0.05). Parasite genotyping revealed that four of the five apparent treatment failures were true recrudescences but the other represented a re-infection detected on day 28. The true frequencies of cure by day 28 were therefore 100% for ASP and 86.7% for SP alone (P=0.02). Adverse effects of treatment (nausea, itching and giddiness) were observed with similar frequencies in the two treatment arms (10.0% of the patients given ASP v. 13.3% of the patients given SP alone; P&gt;0.05). The frequencies of gametocytaemia during follow-up were, however, much lower in the ASP arm than in the SP-only (0.0% v. 23.3%; P=0.005). Thus, although the problems posed by adverse effects were similar in the two treatment arms, ASP appeared markedly better, in terms of fever- and parasite-clearance times and the prevalence of post-treatment gametocytaemia, than SP alone.</abstract><cop>Leeds</cop><pub>Taylor &amp; Francis</pub><pmid>16004704</pmid><doi>10.1179/136485905X36299</doi><tpages>7</tpages></addata></record>
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subjects Adolescent
Antimalarials - adverse effects
Antimalarials - therapeutic use
Artemisinins - adverse effects
Artemisinins - therapeutic use
Biological and medical sciences
Child
Child, Preschool
Drug Combinations
Drug Therapy, Combination
Female
General aspects
Human protozoal diseases
Humans
Infectious diseases
Malaria
Malaria, Falciparum - drug therapy
Male
Medical sciences
Parasitemia - drug therapy
Parasitic diseases
Plasmodium falciparum
Protozoal diseases
Pyrimethamine - adverse effects
Pyrimethamine - therapeutic use
Recurrence
Sesquiterpenes - adverse effects
Sesquiterpenes - therapeutic use
Sudan
Sulfadoxine - adverse effects
Sulfadoxine - therapeutic use
Treatment Failure
Treatment Outcome
title A comparison of the efficacy of artesunate plus sulfadoxine-pyrimethamine with that of sulfadoxine-pyrimethamine alone, in the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan
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