Therapeutic Efficacy Study (TES) For First Line of Antimalaria Drug (Dihydroartemisinin Piperaquine/DHP) in Individuals Infected with Plasmodium falciparum or Plasmodium vivax at Two Sentinel Sites in Indonesia

World Health Organization, Country Office Indonesia0 个研究点目标入组 142 人开始时间: 2022年2月11日最近更新: 2022年2月21日

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 500 asexual parasites/µl for P. falciparum and 250 asexual parasites/µl P. vivax
•presence of axillary temperature 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 aged less than 17 years (age of majority in this country)
•informed assent from any minor participant aged from 12 to age of majority years; and

•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; presence of danger signs in patients with P. vivax infections
•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), included COVID-19;
•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 (include this criterion only if adults are included)
•unable to or unwilling to take pregnancy test or to use contraception for married women; or young females of child bearing age (12 years and above or those who had their menarche) will be excluded due to culturally sensitive reasons in Indonesia.

发起方

World Health Organization, Country Office Indonesia