RESUMO
BACKGROUND: Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects. METHODS: In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP; 250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age. RESULTS: In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had > or =1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%]; P=.06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%; P=.36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated. CONCLUSIONS: The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00167843.
Assuntos
Antimaláricos/administração & dosagem , Malária Falciparum/prevenção & controle , Parasitemia/prevenção & controle , Pirimetamina/administração & dosagem , Sulfadoxina/administração & dosagem , Anemia/induzido quimicamente , Anemia/epidemiologia , Antimaláricos/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Combinação de Medicamentos , Feminino , Gabão/epidemiologia , Hematócrito , Hemoglobinas/metabolismo , Humanos , Incidência , Lactente , Estimativa de Kaplan-Meier , Malária Falciparum/sangue , Malária Falciparum/epidemiologia , Masculino , Parasitemia/sangue , Parasitemia/epidemiologia , Parasitemia/parasitologia , Seleção de Pacientes , Pirimetamina/efeitos adversos , Projetos de Pesquisa , Sulfadoxina/efeitos adversos , Resultado do TratamentoRESUMO
Despite different recommendations from WHO and national authorities, artesunate monotherapy is increasingly used for treating African children with malaria. A 5-day course of oral artesunate (first day: 4 mg/kg body weight, observed intake; and 2 mg/kg body weight on the following days with nonobserved drug intake) yielded a PCR-corrected Day 28 cure rate of 90% (45 of 50 patients; CI 78-97%) in Gabonese children aged between 2 and 18 months. Artesunate was well tolerated, and no severe adverse events were reported.