NL-OMON23822已完成不适用
A Four-arm Trial Comparing Artemether-lumefantrine With or Without Single-dose Primaquine and Sulphadoxine-pyrimethamine/Amodiaquine With or Without Single-dose Tafenoquine to Reduce P. Falciparum Transmission in Mali
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age = 10 years and = 50 years
- •- G6PD-normal defined by Carestart rapid diagnostic test or the OSMMR2000 G6PD qualitative test
- •- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- •- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. = gametocytes recorded in the thick film against 500 white blood cells)
- •- Absence of other non-P. falciparum species on blood film
- •- Hemoglobin = 10 g/dL
- •- Individuals weighing < = 80 kg
- •- No evidence of acute severe or chronic disease
- •- Written, informed consent
排除标准
- •- Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (ß-hCG) will be used.
- •- Detection of a non-P. falciparum species by microscopy
- •- Previous reaction to study drugs / known allergy to study drugs
- •- Signs of severe malaria, including hyperparasitemia (defined as asexual parasitemia > 100,000 parasites / µL)
- •- Signs of acute or chronic illness, including hepatitis
- •- The use of other medication (except for paracetamol and/or aspirin)
- •- Use of antimalarial drugs over the past 7 days (as reported by the participant)
- •- Clinically significant illness (intercurrent illness e.g., pneumonia, pre-existing condition e.g., renal disease, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhea or any signs of malnutrition as defined clinically)
- •- Signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child Pugh stage B or C)
- •- Signs, symptoms or known renal impairment
- •- Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin < 10 g/dL, platelets < 50,000/µl, White Blood - Cell count (WBC) < 2000/µl, serum creatinine >2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
- •- Blood transfusion in the last 90 days.
- •- Consistent with the long half-life of tafenoquine, effective contraception should be continued for 5 half-lives (3 months) after the end of treatment.
- •- History of psychiatric disorders
研究者
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