Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (> 6 months) suffering from uncomplicated P. falciparum malaria.
Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed.
Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.
Visão geral do estudo
Status
Descrição detalhada
To objective of the study:
- To measure the efficacy and safety of AL and DP in children for treating uncomplicated P. falciparum malaria.
- To determine the capacity of each drug combination to protect against re-infection.
- To differentiate recrudescence from re-infections using PCR based methods
- To determine haemoglobin values on days 0 and 42
- To determine genetic polymorphisms in P. falciparum causing reparasitaemia. Study design This will be an open label, randomized, non inferiority trial conducted at the Bandim Health Centre, Guinea-Bissau. Patients with uncomplicated malaria who meet study inclusion criteria will be enrolled, randomised to treatment with either AL or DP. Medication will be provided and first dose given at the health centre.
Efficacy and safety evaluation Treatment outcomes will be early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response as defined by the WHO. All will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow up visit. All adverse events will be recorded in the case record forms.
100µL of blood will be collected on Whatman 3MM filter-paper using a capillary tube on day 0, 7, 14, 28,and 42 and whenever re-parasitaemia is detected. Filter-papers will be dried and then placed inside separate sealed plastic bags.
In order to differentiate recrudescence from a re-infection genotyping using sequential analysis of pf-glurp, pfmsp1 and pfmsp2 will be done. Drug concentrations will be assessed on the week prior to re-parasitaemia. Haemoglobin concentration will be determined on day 0, 3 and 42 using a haemocueTM.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Bissau Codex
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Bissau, Bissau Codex, Guiné-Bissau
- Bandim Health Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Mono-infection with P. falciparum detected by microscopy.
- Parasitemia of 1.000-200.000/µl asexual forms.
- Axillary temperature ≥37.5 ˚C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
- Informed consent
Exclusion Criteria:
- Signs or symptoms of severe malaria
- Presence of general danger signs in children under 5
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to AL, DP or quinine.
- Domicile outside the study area.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: dihydroartemisinin-piperaquine
First dose will be given supervised. The rest will be provided and the parents should take it at home. Dihydroartemisinin-piperaquine dosing as recommended by manufacturer |
Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.
Outros nomes:
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Comparador Ativo: artemether-lumefantrine
First dose will be given supervised. The rest will be provided and the patients should take it at home. Artemether-lumefantrine dosing as recommended by manufacturer |
Artemether-Lumefantrine is given as recommended by manufacturer
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adequate clinical and parasitological response rate at day 42
Prazo: Day 42
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Cumulative percentages of children having successful treatment on day 42.
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Day 42
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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re-infection vs recrudescence
Prazo: Day 42
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Cumulative re-infection and recrudescence rates
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Day 42
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Haemoglobin level
Prazo: Day 42
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Haemoglobin measured on day 42
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Day 42
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Eurartesim2015
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