Evaluation of the efficacy and safety of Artemether +Lumefantrine (Coartem®) with low-dose Primaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in three sites of Savanakhet, Salavanh, and Attopue province, Lao PDR 2022)

Ministry of Health0 个研究点目标入组 300 人开始时间: 2023年3月6日最近更新: 2023年3月13日

适应症

试验速览

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•aged 6 months up to 60 years old;
•mono-infection with P. falciparum and P. vivax confirmed by positive blood smear (no mixed infection);
•P. falciparum parasitaemia of 250-100,000/µl asexual forms;
•P. vivax parasitaemia of 250-60,000/µl asexual forms
•presence of axillary temperature equal or 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; and
•Informed consent from the patient or from a parent or guardian in the case of children.
•informed assent from any minor participant aged from 12 to 18 years; and
•consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active).

•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO );
•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 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);
•Women age 12-18 years old
•a positive pregnancy test or lactating
•Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.

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