Monitoring the Efficacy of ACT for the treatment of uncomplicated Plasmodium falciparum malaria in 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 above 1 year to 65 years
•Mono infection with P. falciparum detected by microscopy
•parasitaemia of 1,000â??100,000/Âµl asexual forms
•presence of axillary >= 37.5 Â°C or history of fever during the past 48 hrs
•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
•informed assent from any minor participant aged from 12 to age of majority (18 years old) and
•consent for pregnancy testing from female of child-bearing age and from their parent or guardian if under the age of majority 18 years old

•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
•female aged from 12 years and age of majority
•weight under 5 kg
•haemoglobin < 8 g/dl
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition,
•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) (select one or more of the three options, and delete those that are not applicable)
•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;
•unable to or unwilling to take contraceptives for women of child-bearing age (defined as age > 12 years and sexually active

发起方

WHO through WR India