Efficacy and safety of the combination dihydroartemisinin-piperaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria in Champasack province, Laos PDR

Ministry of Health0 个研究点目标入组 100 人开始时间: 2018年10月5日最近更新: 2018年11月12日

适应症

试验速览

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•Age between 5 months and above to 60 years old as maximum age;
•- P. falciparum confirmed by microscopy;
•-P. Falciparum parasitaemia of 1000-100,000/µl asexual forms;
•-Presence of axillary temperature more than 37.5 °C 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;
•-Informed consent from the patient or from a parent or guardian in the case of children aged less than 12 year old;
•-Informed assent from any minor participant aged more than 12 years and less than 18 years old ;
•-Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.

•-presence of general danger signs in children aged under 5 months or signs of severe falciparum malaria according to the definitions of WHO
•-weight under 5 kg;
•-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 < 115 mm);
•-presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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);
•-Female patients of child-bearing age, defined as those who menstruate and who are sexually active, will be not included in the study, because they are always not honest to tell on their sexual intercourse experience, which also reflects local culture if they are not yet married.
•-a positive pregnancy tested or lactating women; and
•-Unable to or unwilling to take pregnancy test or to use contraception for women of child- bearing age and who are sexually active.

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