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

David Schellenberg Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Elizeus Kahigwa Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Chris Drakeley Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Athumani Malende Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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John Wigayi Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Chris Msokame Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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John J Aponte Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Marcel Tanner Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Hassan Mshinda Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Clara Menendez Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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Pedro L Alonso Unidad de Epidemiologia, Hospital Clinic, Barcelona, Spain.

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DOI:
https://doi.org/10.4269/ajtmh.2002.67.17
Volume/Issue:
Volume 67: Issue 1
Page(s):
17–23
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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.

Author Notes

Published Online:
Jul 2002
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
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