The safety and efficacy of sulfadoxine-pyrimethamine, amodiaquine, and their combination in the treatment of uncomplicated Plasmodium falciparum malaria


Schellenberg, D; Kahigwa, E; Drakeley, C; Malende, A; Wigayi, J; Msokame, C; Aponte, JJ; Tanner, M; Mshinda, H; Menendez, C; Alonso, PL; (2002) The safety and efficacy of sulfadoxine-pyrimethamine, amodiaquine, and their combination in the treatment of uncomplicated Plasmodium falciparum malaria. The American journal of tropical medicine and hygiene, 67 (1). pp. 17-23. ISSN 0002-9637

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Abstract

The safety and efficacy of amodiaquine (AQ), sulfadoxine-pyrimethamine (SP), and coadministered AQ+SP was assessed in 351 Tanzanian children (age range, 6-59 months) with uncomplicated Plasmodium falciparum malaria. This open, randomized study followed the 28-day World Health Organization (WHO) protocol and evaluated safety using clinical and laboratory parameters. Children receiving SP were more likely to vomit during follow-up (32% vs. 17%: P = 0.03), and SP alone resulted in prolonged fever clearance times. Although Day 7 and Day 14 clinical and parasitological cure rates were similar, by Day 28 45% of children treated with AQ demonstrated R1 resistance and 27.5% were clinical failures compared with 25% and 6.3%, respectively, for SP alone. Coadministered AQ+SP was safe, combined the greater clinical (96.2%) and parasitological (64.2%) efficacy of SP with the more rapid symptom resolution of AQ, and reduced the incidence of gametocytemia during follow-up (AQ+SP 12.6% vs. SP 29.9%; P = 0.001). The level of R1 resistance to SP may herald a rapid decline in its efficacy as SP drug pressure increases. Coadministration of AQ+SP may delay this.

Item Type: Article
Keywords: Amodiaquine/administration & dosage/*therapeutic use, Animals, Antimalarials/administration & dosage/*therapeutic use, Child, Preschool, Drug Combinations, Drug Therapy, Combination, Female, Human, Infant, Malaria, Falciparum/*drug therapy/parasitology, Male, Plasmodium falciparum/isolation & purification, Pyrimethamine/administration & dosage/*therapeutic use, Sulfadoxine/administration & dosage/*therapeutic use, Support, Non-U.S. Gov't, Treatment Outcome, Amodiaquine, administration & dosage, therapeutic use, Animals, Antimalarials, administration & dosage, therapeutic use, Child, Preschool, Drug Combinations, Drug Therapy, Combination, Female, Human, Infant, Malaria, Falciparum, drug therapy, parasitology, Male, Plasmodium falciparum, isolation & purification, Pyrimethamine, administration & dosage, therapeutic use, Sulfadoxine, administration & dosage, therapeutic use, Support, Non-U.S. Gov't, Treatment Outcome
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Immunology and Infection
Faculty of Infectious and Tropical Diseases > Dept of Disease Control
PubMed ID: 12363058
Web of Science ID: 178069600003
URI: http://researchonline.lshtm.ac.uk/id/eprint/15440

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