A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 主要终点
- Prevalence of parasitaemia on day 28 post treatment.
研究概览
简要总结
Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.
详细描述
Primary objective:
To determine the effect of AQ, SP and the AQ+SP combination compared with CQ treatment on the prevalence of peripheral parasitaemia on days 14 and 28 post treatment.
Secondary objectives:
- To compare the incidence of adverse events in the treatment groups.
- To compare the effect of study drugs on maternal haemoglobin on 14 and 28 days post treatment, and at delivery.
- To compare the effect of study drugs on peripheral and placental parasite densities at delivery.
- To compare the effect of study drugs on birth weight at delivery.
- To assess the effect modifications of gestational age, parity, gravidity, prior antimalarial use, presence or absence of symptoms at enrolment, baseline parasite density and baseline Hb on the parasitological and haematological responses to the test drugs.
- To assess the accuracy of the OptiMAL antigen test for detecting peripheral parasitaemia compared to microscopy.
- To compare the overall incidence of adverse pregnancy outcomes (abortion, stillbirth, congenital abnormality, prematurity and intrauterine deaths) in the study group to local rates obtained from St Theresa's Hospital's records.
Study location and population:
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
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age of at least 16 weeks.
- •P. falciparum parasitaemia of any density with or without symptoms.
- •Informed consent.
- •No known adverse reaction to any of the study drugs.
- •Residence in the study area.
排除标准
- •Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
- •History of severe adverse drug reactions to co-trimoxazole in the past.
- •Haemoglobin concentration below 5.0 g/dl.
- •Severe malaria.
结局指标
主要结局
Prevalence of parasitaemia on day 28 post treatment.
Prevalence of parasitaemia on day 14 post treatment.
次要结局
- Prevalence of postpartum anaemia.
- Change in maternal haemoglobin concentrations at days 14 and 28 following treatment.
- Prevalence of peripheral parasitaemia at delivery.
- Incidence of adverse drug events within seven days following treatment.
- Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.
- Prevalence of postpartum parasitaemia.
- Prevalence of placental parasitaemia at delivery.
- Proportions of abnormal biochemistry and white blood cell values on days 14 and 28 post treatment.
- Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and the area under receiver operating characteristic (ROC) curve for the OptiMAL antigen test.
- Incidences of adverse pregnancy outcomes in the study group.
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine