A randomized, placebo-controlled, double-blind trial on sulfadoxine–pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria
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.
Document Type: Research Article
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: 2005-06-01