PACTR201905721140808Other3 期
Safety and Efficacy of Intermittent Presumptive Treatment in Pregnancy With Sulfadoxine-Pyrimethamine using Rapid Diagnostic Test Screening And Treatment at First Antenatal Care Visit
Tropical Diseases Research Centre0 个研究点目标入组 392 人开始时间: 2019年5月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 392
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •Gestational age of 16 to 24 weeks at enrolment;
- •Asymptomatic* on presentation
- •Hb = 7 g/dL;
- •HIV negative at enrolment
- •No history of IPTp-SP or antimalarial drug use during the current pregnancy
- •At least 15 years old;
- •Residence within the health facility catchment’s area;
- •Willing to deliver at the health facility;
- •Willing to adhere to the study requirements (HIV voluntary counselling and testing (VCT included);
- •Ability to provide written informed consent; if the woman is minor of age/not emancipated, the consent must be
- •given by a parent or legal guardian according to national law (An assent will also be obtained from the participant).
- •Asymptomatic defined as absence of fever (temperature <37.5 °C) at baseline; less than three of the following symptoms: fever in the past 24 h, weakness/fatigue; muscle and/or joint aches, headache
排除标准
- •HIV positive or unknown at enrolment
- •Hb<7 g/dl
- •History of allergic reactions to the study drugs;
- •History of known pregnancy complications or bad obstetric history including pre-existing illness likely to cause complication of pregnancy such as repeated abortions, stillbirths or eclampsia;
- •History or presence of major illnesses likely to influence pregnancy outcome including hypertension, diabetes
- •mellitus, asthma, epilepsy, renal disease, liver disease, fistula repair, heart disease, or active tuberculosis;
- •Current cotrimoxazole prophylaxis or ARV treatment;
- •Any significant illness at the time of screening that requires hospitalization, including severe malaria;
- •Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment
- •Prior enrolment in the study or concurrent enrolment in another study.
- •Unable to take oral medication
- •Clear evidence of recent (2 weeks) treatment with antimicrobials with antimalarial activity (clindamycin,
- •azithromycin, clarithromycin, levofloxacin etc.);
- •On at least one of the following drugs: Pentamidine, Antiarrhythmic agents (e.g. amiodarone, sotalol),
- •Antihistamines (e.g. promethazine), Antifungals (systemic): ketoconazole, fluconazole, itraconazole, Diuretics (e.g.
- •hydrochlorothiazide, furosemide), Antipsychotics (neuroleptics): haloperidol, thioridazine, Antidepressants:
- •imipramine, citalopram, escitalopram, Antiemetics: domperidone, chlorpromazine, ondansetron
研究者
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