Efficacy and safety of ACT for the treatment of uncomplicated Plasmodium falciparum malaria across International borders of India. - TES

WHO through WR India0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•age between minimum age 1 year to maximum age 65 years
•mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
•parasitaemia of (1000)â??(100000)/Âµl asexual forms
•presence of axillary or tympanic temperature >= 37.5 Â°C or oral or rectal temperature of >= 38 Â°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 age of majority;
•informed assent from any minor participant aged from 12 to age of majority years; and
•Only if consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of majority years.

•presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO
•weight under 5 kg;
•haemoglobin < 8g/dl;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below â??3 z-score, or 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);
•a positive pregnancy test or breastfeeding; and
•unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age > 12 years and sexually active).

发起方

WHO through WR India