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Free Content A randomized, placebo-controlled, double-blind trial on sulfadoxine–pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria

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Abstract:

Summary

The therapeutic efficacy of sulfadoxine–pyrimethamine (SP) alone, SP plus amodiaquine (AQ), and SP plus artesunate (AS) was assessed in a randomized, placebo-controlled, and double-blind trial among 438 children with uncomplicated Plasmodium falciparum malaria in northern Ghana. Clinical and parasitological responses were monitored for 28 days following treatment; 86%, 98% and 97% of SP-, SP + AQ-, and SP + AS-treated patients achieved adequate clinical and parasitological response (ACPR) within 2 weeks, respectively. Parasite clearance was better with SP + AS than with SP or SP + AQ treatment but re-infections were more common. Polymerase chain reaction (PCR)-corrected rates of ACPR at day 28 were 72.2% for SP, 94.1% for SP + AQ (P < 0.0001), and 94.5% for SP + AS (P < 0.0001). Gametocyte prevalence and density 1 week after treatment were highest in children treated with SP, and lowest in patients receiving SP + AS. No severe adverse events attributable to study medication were observed. In northern Ghana, more than one of four children suffered SP treatment failure within 4 weeks. Both SP + AQ and SP + AS are efficacious alternative therapeutic options in this region. Although SP + AS and SP + AQ treatments have virtually identical cure rates, rapid parasite clearance and pronounced gametocidal effects are the advantages of the former, whereas cost and a lower rate of late re-infections are those of the latter.

Keywords: Ghana; amodiaquine; artesunate; malaria; sulfadoxine–pyrimethamine

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2005.01427.x

Affiliations: 1: Institute of Tropical Medicine, Charité, Humboldt University, Berlin, Germany 2: Department of Medical Microbiology, University Medical Centre St. Radboud, Nijmegen, The Netherlands 3: Regional Health Administration, Takoradi, Western Region, Ghana 4: School of Medicine and Health Sciences, University for Development Studies, Tamale, Northern Region, Ghana 5: Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Centre, Amsterdam, The Netherlands

Publication date: June 1, 2005

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