NCT01184911撤回4 期
Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Parasite clearance
研究概览
简要总结
The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •16-26 weeks gestation based on LMP or ultrasound or fundal height
- •Axillary temperature <37.5 degrees C
- •Informed consent
- •HIV status known and negative
- •Blood smear positive for falciparum malaria
排除标准
- •History of hypersensitivity reaction to SP or components of SP
- •Axillary temperature ≥37.5 degrees C
- •History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month
- •Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits
- •Hemoglobin level < 5 gm/dL
- •These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
研究组 & 干预措施
SP
Experimental
Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria
干预措施: Sulfadoxine-pyrimethamine (Drug)
结局指标
主要结局
Parasite clearance
时间窗: 42 days
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in InfantsMalariaAnemiaNCT00206739Bernhard Nocht Institute for Tropical Medicine1,070
Unknown
4 期
Intermittent Antimalaria Treatment With SP in African ChildrenMalariaAnemiaNCT00168948Charite University, Berlin, Germany1,200
终止
4 期
A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon IslandsMalaria in PregnancyMalariaNCT00964691Ministry of Health and Medical Services, Solomon Islands2,504
已完成
不适用
Assessment of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in MalawiMalaria in PregnancyNCT01120145Centers for Disease Control and Prevention1,410
已完成
2 期
Navrongo Drug Options for IPT in Pregnancy TrialMalariaNCT00146783London School of Hygiene and Tropical Medicine3,642