Amodiaquine, sulfadoxine/pyrimethamine, and combination therapy for treatment of uncomplicated falciparum malaria in Kampala, Uganda: a randomised trial


Staedke, SG; Kamya, MR; Dorsey, G; Gasasira, A; Ndeezi, G; Charlebois, ED; Rosenthal, PJ; (2001) Amodiaquine, sulfadoxine/pyrimethamine, and combination therapy for treatment of uncomplicated falciparum malaria in Kampala, Uganda: a randomised trial. Lancet, 358 (9279). pp. 368-74. ISSN 0140-6736 DOI: https://doi.org/10.1016/S0140-6736(01)05557-X

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Abstract

BACKGROUND: Increasing Plasmodium falciparum resistance to chloroquine in sub-Saharan Africa necessitates use of alternative antimalarial agents. Affordable alternative treatments include sulfadoxine/pyrimethamine and amodiaquine. Combination of antimalarial agents can increase therapeutic efficacy and delay emergence of drug resistance. We compared the efficacy of sulfadoxine/pyrimethamine, amodiaquine, and an amodiaquine/sulfadoxine/pyrimethamine combination for treatment of uncomplicated malaria in a region of high chloroquine resistance. METHODS: Patients with symptoms of uncomplicated falciparum malaria and confirmed disease in Kampala, Uganda, were randomly assigned to receive sulfadoxine/pyrimethamine (25 mg/kg sulfadoxine, and 1.25 mg/kg pyrimethamine) plus placebo; amodiaquine (25 mg/kg) plus placebo; or amodiaquine plus sulfadoxine/pyrimethamine. Patients were followed up for 14 days, and clinical and parasitological outcomes were assessed. FINDINGS: 90% (400/445) of patients enrolled in the study successfully completed 14 days of follow-up. Treatment failure based on clinical criteria occurred in 13 of 131 (10%) patients on sulfadoxine/ pyrimethamine, nine of 131 (7%) on amodiaquine, and four of 138 (3%) on amodiaquine/sulfadoxine/pyrimethamine. Based on parasitological criteria, treatment failed in 26%, 16%, and 10% of these patients, respectively. Amodiaquine/sulfadoxine/pyrimethamine was significantly more effective than sulfadoxine/pyrimethamine alone in children aged younger than 5 years (clinical failure in 3.5% vs 13.9%, respectively, risk difference 10.4% [95% CI, 1.6-19.3] p=0.021; parasitological failure in 12.8% vs 26.4%, risk difference 13.6% [1.2-26.0] p=0.041). INTERPRETATION: Sulfadoxine/pyrimethamine, amodiaquine, and amodiaquine/sulfadoxine/pyrimethamine were all effective for treatment of uncomplicated falciparum malaria in Uganda. The amodiaquine/sulfadoxine/pyrimethamine combination was the most effective, and could be the optimum low-cost alternative to chloroquine in Africa.

Item Type: Article
Keywords: Adolescent, Amodiaquine/administration & dosage/therapeutic use, Antimalarials/administration & dosage/*therapeutic use, Child, Child, Preschool, Drug Therapy, Combination, Female, Humans, Malaria, Falciparum/*drug therapy/epidemiology, Male, Pyrimethamine/administration & dosage/therapeutic use, Sulfadoxine/administration & dosage/therapeutic use, Time Factors, Treatment Outcome, Uganda/epidemiology, Adolescent, Amodiaquine, administration & dosage, therapeutic use, Antimalarials, administration & dosage, therapeutic use, Child, Child, Preschool, Drug Therapy, Combination, Female, Humans, Malaria, Falciparum, drug therapy, epidemiology, Male, Pyrimethamine, administration & dosage, therapeutic use, Sulfadoxine, administration & dosage, therapeutic use, Time Factors, Treatment Outcome, Uganda, epidemiology
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Malaria Centre
PubMed ID: 11502317
Web of Science ID: 170235100012
URI: http://researchonline.lshtm.ac.uk/id/eprint/10201

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