Efficacy of Sulphadoxine-pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,642
- 试验地点
- 1
- 主要终点
- HB at delivery
研究概览
简要总结
In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.
详细描述
Background Pregnant women, particularly during the first and second pregnancy, have a high risk of Plasmodium falciparum infection and these infections are often asymptomatic but lead to maternal anaemia and low birth-weight. One approach to preventing malaria in pregnancy is prompt effective management of clinical malaria. In areas of moderate and high transmission however, peripheral parasitaemia is not a sensitive indicator as many women with placental parasitaemia may not have peripheral parasitaemia. Another option is to administer full curative doses of an effective antimalarial drug at predefined intervals during pregnancy (IPTp) without screening for parasitaemia. The efficacy of IPTp has been studied mostly in areas of high perennial transmission in Kenya and Malawi. IPTp has however been little investigated in West Africa where transmission is often intense and highly seasonal. It may not be appropriate to translate results between areas with different ranges of transmission intensities across the sub-Saharan African region and there is a need to study the effect of IPTp in highly seasonal intense transmission areas in West Africa.
IPTp with SP has been shown to be effective in reducing maternal anaemia, prevalence of placental parasitaemia and the incidence of low birth weight. SP offers a reasonable combination of ease of use and associated increased compliance, low cost, and relatively good tolerance and safety. However, the useful therapeutic life (UTL) predicted for SP is likely to be short, in part due to its prolonged half-life, causing a higher probability of selecting resistant strains and consequent rapid development of resistance. The emergence and spread of SP resistance will increasingly undermine this strategy, depleting the currently available and affordable drugs usable for intervention during pregnancy. It is therefore important that alternative antimalarials that are safe and effective in pregnancy are identified.
Specific primary objective To assess and compare the efficacy of a combination of sulphadoxine-pyrimethamine and amodiaquine, sulphadoxine-pyrimethamine or amodiaquine used as IPTp, in reducing the incidence of anaemia(Hb<11g/dl) at weeks 34-36 among primigravidae and secundigravidae.
Specific secondary objectives
To evaluate the effect of SP/AQ, SP or AQ on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with gestation between 18-32weeks,
- •willing to give written consent to take part in the study
- •Resident in the study area and available for follow-up.
排除标准
- •Presentation with clinical symptoms of malaria (this would not affect subsequent enrollment at a later date),
- •Known allergies or reactions to study drugs,
- •Medical conditions needing hospital admission.
结局指标
主要结局
HB at delivery
时间窗: with inseven 7days of delivery
次要结局
- tolerance and adverse events after taking study drugs
- molecular markers of drug resistance to SP and Amodiaquine
- placental malaria(on the day of delivery)
- maternal peripheral parasitaemia at delivery(within seven days of dellivery)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine