A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum in Semi-immune Adults Living in the Kassena-Nankana District of Northern Ghana
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 主要终点
- First occurrence of malaria infection
研究概览
简要总结
This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing subjects in good general health.
- •Males aged 18 to 60; females aged 50 to
- •Subjects who planned to stay in the study area until the end of the study.
排除标准
- •Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.
- •Subjects with a personal or family history of seizures or frank psychiatric disorder.
- •Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
- •Females who were lactating.
- •Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
- •Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
- •Subjects with known hypersensitivity to any of the study drugs.
- •Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
- •Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
- •Subjects with any of the following laboratory values: haemoglobin (Hb) <8g/dL, platelets <80,000/mm3, white blood cell count (WBC) <3000/mm3, creatinine >1.5mg/dL, alanine transaminase (ALT) >60IU or 1+ haematuria as detected by urine dipstick.
研究组 & 干预措施
Placebo
Placebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Placebo (Drug)
Tafenoquine 25mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Tafenoquine 25mg (Drug)
Tafenoquine 50mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Tafenoquine 50mg (Drug)
Tafenoquine 100 mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Tafenoquine 100 mg (Drug)
Tafenoquine 200 mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Tafenoquine 200 mg (Drug)
Mefloquine 250 mg
Mefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
干预措施: Mefloquine 250 mg (Drug)
结局指标
主要结局
First occurrence of malaria infection
时间窗: 16 weeks
First occurrence of malaria infection as documented by a positive malaria smear.
次要结局
- Time to confirmation of parasitaemia(16 weeks)