A study investigating the efficacy of artemisinin combination therapy to prevent postpartum malaria and as a treatment for uncomplicated malaria in young infants.

The University of Western Australia0 个研究点目标入组 180 人开始时间: 2020年9月21日最近更新: 2020年9月28日

适应症

试验速览

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•Postpartum study (Main trial)
•i) >=18 years of age
•ii) Peripheral blood slide negative for malaria at delivery (slide positive women will receive conventional artemether-lumefantrine treatment and are not eligible for recruitment).
•ii) They have not received a study intervention in the previous 4 weeks.
•iii) They have not required medical/surgical intervention for complications during delivery, other than an episiotomy and broad spectrum antibiotic treatment.
•iv) They have no significant co-morbidity
•v) They can attend follow-up assessments over the full 6 months
•Infant study (Sub-study 2)
•i) infant born to Main trial study mother within the last 6 months.
•ii) positive blood slide or polymerase chain reaction positive for malaria during the 6 months' follow-up

•i) < 18 years of age
•ii) Husband/ father do not grant informed consent (as per Papua New Guinean custom)
•iii) Participant has a positive malaria blood slide or rapid diagnostic test at time of delivery.
•iv) Participant has a pre-term delivery
•v) Neonate demonstrating signs of illness or low APGAR score at delivery
•vi)Participant has received treatment with a study intervention in the past 4 weeks.
•vii) Participant has signs of a significant concomitant disease including malnutrition, tuberculosis, and pneumonia.
•viii) Surgical intervention was required during delivery.
•vi) Participant residence is outside health centre catchment area.

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