Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

Institute of Tropical Medicine0 个研究点目标入组 3,480 人开始时间: 2010年8月17日最近更新: 2023年5月29日

适应症

试验速览

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•1. gestation >= 16 weeks and < 37 weeks (women should not be included one week before the expected date of delivery)
•2. P. falciparum monoinfection of any density, with or without symptoms
•3. Hb >= 7 g/dL
•4. At least 15 years old
•5. Residence within the health facility cathment's area
•6. willing to deliver at the health facility
•7. willing to adhere to the study requirements (including, in Zambia and Malawi, HIV voluntary counseling and testing)
•8. 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 (however, in this case, also the minor woman will sign the consent form, to document that she is freely giving her assent to take part in the study)

•1. history of allergic reactions to the study drugs
•2. history of known pregnancy complications or bad obstretic history such as repeated stillbirht or eclampsia
•3. history of presence of major ilnesses likely to influence the pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis
•4. current cotrimoxazole prohylaxis or ARV treatment
•5. any significant illness at the time of screening that requires hospitalization, including severe malaria
•6. intent to move out of the study cathment's area before delivery or deliver at relative's home out of the cathment's area
•7. prior enrolment in the study or concurrent enrolment in another study
•8. unable to take oral medication
•9. clear evidence of recent (1 week) treatment with antimicrobials with antimalarial activity (clindamycin; azythromycin; etc.)

发起方

Institute of Tropical Medicine