Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 6 sentinel sites in Indonesia

Ministry of Health0 个研究点目标入组 1,200 人开始时间: 2014年7月16日最近更新: 2020年1月13日

适应症

试验速览

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•*age between one year (weight more than 5 kgs) to 65 years old;
•*mono-infection with P. falciparum or P. vivax detected by microscopy;
•*parasitaemia of more than 1000/µl asexual parasites
•*presence of axillary temperature equal to or greater than 37.5 degrees Centigrade or history of fever during the past 24 h;
•*ability to swallow oral medication;
•*ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
•*informed consent from the patient or from a parent or guardian in the case of children.

•*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1); presence of danger signs as described in appendix 1 in patients with P. vivax infections
•*Unmarried females over 12 years of age or who have had their menarche
•*mixed or mono-infection with another Plasmodium species detected by microscopy;
•*presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
•*presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
•* regular medication, which may interfere with antimalarial pharmacokinetics;
•* history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
•* a positive pregnancy test or breastfeeding in eligible married women (include this criterion only if adults are included)

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