Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,820
- 试验地点
- 5
- 主要终点
- Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.
研究概览
简要总结
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.
详细描述
The current recommendation by the World Health Organization (WHO) to prevent malaria infection in pregnancy in areas of stable malaria transmission relies on:
- Prompt and effective case management of malaria illness
- The use of intermittent preventive treatment (IPTp) with at least 2 treatment doses of sulfadoxine-pyrimethamine (SP) and
- The use of insecticide treated nets (ITNs)
However, the spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp.
HIV infection increases susceptibility to malaria and may reduce the efficacy of interventions. The evaluation of alternative antimalarials for IPTp is thus urgently needed also involving HIV infected women.
Of all the current available alternative antimalarial drugs, mefloquine (MQ) is the one that offers the most comparative advantages to SP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Permanent resident in the area
- •Gestational age at the first antenatal visit ≤ 28 weeks
- •Signed informed consent
- •Agreement to deliver in the study site's maternity(ies) wards
- •Permanent resident in the area.
- •Gestational age at the first antenatal visit ≤ 28 weeks
- •HIV seropositive (after voluntary counseling and testing)
- •Indication to receive CTX prophylaxis (according to the national guidelines)
- •Signed informed consent
- •Agreement to deliver in the study site's maternity(ies) wards.
排除标准
- •Residence outside the study area or planning to move out in the following 18 months from enrollment
- •Gestational age at the first antenatal visit > 28 weeks of pregnancy
- •Known history of allergy to sulfa drugs or mefloquine
- •Known history of severe renal, hepatic, psychiatric or neurological disease
- •MQ or halofantrine treatment in the preceding 4 weeks
- •HIV infection
- •Participating in other studies
- •Residence outside the study area or planning to move out in the following 10 months from enrollment
- •Gestational age at the first antenatal visit > 28 weeks of pregnancy
- •Known history of allergy to CTX or MQ
- •Known history of severe renal, hepatic, psychiatric or neurological disease
- •MQ or halofantrine treatment in the preceding 4 weeks
研究组 & 干预措施
Trial 1: IPTp-SP+LLITNs
HIV-negative pregnant women receiving 2 doses of IPTp (500mg of sulfadoxine and 25 mg of pyrimethamine) in the context of long lasting Insecticide Treated Nets (LLITNs)
干预措施: Sulphadoxine-pyrimethamine (Drug)
Trial 1: IPTp-MQ (full dose) + LLITNs
HIV-negative pregnant women receiving 2 full doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs)
干预措施: Mefloquine (full dose) (Drug)
Trial 1: IPTp-MQ (split dose)+LLITNs
HIV-negative pregnant women receiving 2 doses of MQ as IPTp split dose over 2 days (15mg/kg) in the context of long lasting Insecticide Treated Nets (LLITNs
干预措施: Mefloquine (split dose) (Drug)
Trial 2: CTX+IPTp-Placebo+LLITNs
HIV-positive pregnant women receiving 3 doses of IPTp (placebo) in the context of long lasting Insecticide Treated Nets (LLITNs)
干预措施: placebo (Drug)
Trial 2: CTX + IPTp-MQ+ LLITNs
HIV-positive pregnant women receiving 3 doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs)
干预措施: mefloquine (Drug)
结局指标
主要结局
Trial 1 (IPTp MQ vs IPTp SP): Low birth weight.
时间窗: day 0, birth
Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia.
时间窗: day 0, delivery
次要结局
- Trial 1: Prevalence of placental P. falciparum infection. Prevalence of moderate maternal anaemia at delivery.(day 0, delivery)
- Trial 2: Prevalence of placental P. falciparum infection. Prevalence of low birth weight babies (< 2500 g).(day 0, birth)