Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Xepon Inter-District Hospital, Savannakhet Province, Laos

niversity of Oxford (UK)0 个研究点目标入组 40 人开始时间: 2010年6月24日最近更新: 2015年1月13日

试验速览

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•1. Male and female, aged greater than 10 years
•2. Female patients between ages of 10 and 12 years old, provided they have not reached menarche, and those who have passed through the menopause
•3. Mono-infection with P. falciparum as detected by microscopy
•4. Parasitaemia of 10,000 - 175,000/µl asexual forms
•5. Presence of axillary or tympanic temperature greater than or equal to 37.5°C or oral or rectal temperature of greater than or equal to 38°C or history of fever during the past 24 hours
•6. Ability to swallow oral medication
•7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
•8. Informed consent from the patient or from a parent or guardian in the case of children

•1. Presence of general danger signs or severe falciparum malaria according to the definitions of the World Health Organization (WHO, 2000)
•2. Mixed or mono-infection with another Plasmodium species detected by microscopy
•3. 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 less than 110 mm)
•4. Presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases
•5. Regular medication, which may interfere with antimalarial pharmacokinetics
•6. Received antimalarial drugs in the previous 48 hours
•7. History of hypersensitivity reactions or contraindications to any of the medicine(s) used
•8. Female patients of child-bearing age, defined as those who menstruate or are aged over 12 years and have not reached the menopause
•9. Breastfeeding
•10. Splenectomy

发起方

niversity of Oxford (UK)