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1.
Lancet Child Adolesc Health ; 6(2): 86-95, 2022 02.
Article in English | MEDLINE | ID: mdl-34871570

ABSTRACT

BACKGROUND: Single-dose tafenoquine 300 mg is approved for Plasmodium vivax malaria relapse prevention in patients at least 16 years old. We aimed to determine appropriate oral tafenoquine paediatric dosing regimens, including a dispersible formulation, and evaluated tafenoquine efficacy and safety in children infected with P vivax. METHODS: This open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 study enrolled children (2-15 years) who weighed 5 kg or more, with glucose-6-phosphate dehydrogenase activity more than 70% of the local population median, and P vivax malaria infection, from three community health centres in Vietnam and one in Colombia. Patients received 3-day chloroquine plus oral single-dose tafenoquine as dispersible tablets (50 mg) or film-coated tablets (150 mg). Dosing groups were assigned by body weight, predicted to achieve similar median exposures as the approved 300 mg dose for adults: patients who weighed 5 kg or more to 10 kg received 50 mg, those who weighed more than 10 to 20 kg received 100 or 150 mg, those who weighed more than 20 to 35 kg received 200 mg, and patients who weighed more than 35 kg received 300 mg. Population pharmacokinetic analysis was done to develop a paediatric population pharmacokinetic model. The primary outcome was the tafenoquine area under the concentration-time curve extrapolated to infinity (AUC[0-∞]) by patient body weight in the pharmacokinetic population (all patients who received tafenoquine with at least one valid pharmacokinetic sample) estimated from a paediatric population pharmacokinetic model. A key prespecified secondary outcome was 4-month recurrence-free efficacy. This trial is registered with ClinicalTrials.gov, NCT02563496. FINDINGS: Between Feb 6, 2017, and Feb 17, 2020, 60 patients were enrolled into the study: 14 (23%) received tafenoquine 100 mg, five (8%) 150 mg, 22 (36%) 200 mg, and 19 (32%) 300 mg. The paediatric population pharmacokinetic model predicted adequate tafenoquine exposure at all doses. The predicted median AUC(0-∞) was 73·8 (90% prediction interval [PI] 46·9-117·0) µg × h/mL with the 50 mg dose for patients who weighed 5 kg or more to 10 kg, 87·5 (55·4-139·0) µg × h/mL with the 100 mg dose for body weight more than 10 to 20 kg, 110·7 (70·9-174·0) µg × h/mL with the 200 mg dose for body weight more than 20 to 35 kg, and 85·7 (50·6-151·0) µg × h/mL with the 300 mg dose for body weight more than 35 kg. 4-month recurrence-free efficacy was 94·7% (95% CI 84·6-98·3). Adverse events were consistent with previous studies, except for the seven (12%) of 60 patients who had post-dose vomiting or spitting with the 50 mg dispersed tablet. Following mitigation strategies, there were no additional occurrences of this adverse event. There were no deaths during the study. INTERPRETATION: For the prevention of P vivax relapse in children, single-dose tafenoquine, including a dispersible formulation, had exposure, safety, and efficacy consistent with observations in adolescents and adults, notwithstanding post-dose vomiting. FUNDING: GlaxoSmithKline and Medicines for Malaria Venture. TRANSLATIONS: For the Vietnamese and Spanish translations of the abstract see Supplementary Materials section.


Subject(s)
Aminoquinolines/administration & dosage , Aminoquinolines/pharmacokinetics , Aminoquinolines/therapeutic use , Antimalarials/administration & dosage , Antimalarials/pharmacokinetics , Antimalarials/therapeutic use , Malaria, Vivax/drug therapy , Adolescent , Area Under Curve , Child , Child, Preschool , Chloroquine/administration & dosage , Female , Humans , Male , Recurrence , Secondary Prevention , Tablets
2.
Rev. bras. crescimento desenvolv. hum ; 13(1): 5-10, jan.-jul. 2003.
Article in Portuguese | LILACS | ID: lil-344537

ABSTRACT

A partir da consideraçäo de diferenças entre a civilizaçäo ocidental e a oriental na maneira de conceber as relaçöes entre os elementos constitutivos da cultura foram observados os processos e a construçäo dos processos de identificaçäo das relaçöes homem-mulher, adulto-criança, hierarquia-subordinaçäo nas culturas da Asia que estäo atualmente margeando a modernidade devido à mundializaçäo das referências culturais. Baseado em observaçöes clínico-antropológicas que mostraram que certos rituais da acolhida do recém-nascido vietnamita persistem em sua significaçäo moderna. Descreve e explica o significado tradicional de alguns destes rituais: o fio no pulso; o desenho da sobrancelha; a massagem; o processo de nomeaçäo; a entrado do neonato no espaço domiciliar; as festas do primeiro mês e do primeiro aniversário, mostrando as alteraçöes dentro do novo contexto


Subject(s)
Culture , Infant, Newborn , Interpersonal Relations , Vietnam
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