A Multi-center, Open-label, Randomized Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- 63-day PCR-adjusted parasitological cure of P. vivax
研究概览
简要总结
The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. As primaquine can not be used in pregnant women, these women remain at risk of relapse. As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options. The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age >16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus
- •Normal fetal heart beat detected by Doppler
- •Presence of asexual P. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear)
- •Willing to sign or thumb print informed consent
- •Willing to return for scheduled follow up visits for treatment and observation until delivery
- •Willing to deliver in health facility
排除标准
- •Pregnancy < 16 weeks
- •Microscopically confirmed P. falciparum or mixed infection/ parasitemia (P. vivax and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)
- •History of allergy or hypersensitivity to interventional drugs
- •Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)
- •Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)
- •History or family history of epilepsy or psychiatric disorder
- •Presence of signs and symptoms of severe malaria, severe illness, or danger signs
- •Hemoglobin < 7 g/dl
- •Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).
- •History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV/ AIDS, known hemoglobinopathy
- •Participant's inability to return for follow up visits
- •Age <15 years
研究组 & 干预措施
Mefloquine- Artesunate
Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
干预措施: Mefloquine- Artesunate (Drug)
Artemether-Lumefantrine
Artemether-Lumefantrine, Lumet, Cipla 4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
干预措施: Artemether-Lumefantrine (Drug)
Chloroquine
Chloroquine (Farmaguinhos, Brazil): Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
干预措施: Chloroquine (Drug)
结局指标
主要结局
63-day PCR-adjusted parasitological cure of P. vivax
时间窗: 63 days
次要结局
未报告次要终点