Safety and Efficacy Evaluation of Artemisinin-based Combination Therapy for the Treatment of Uncomplicated Plasmodium vivax Malaria - : Artemisinin-based Combination Therapy Plasmodium vivax

Fundação Oswaldo Cruz0 个研究点开始时间: 2014年9月10日最近更新: 2023年5月29日

试验速览

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•Age between 18 and 70, or weight between 50 kg and 80 kg; Mono-infection by P. Vivax confirmed by microscopy; Asexual parasite count > 250/µl; Axillary temperature > 37,5 °C or history of fever during the 48h prior to recruitment; Ability to swallow the medicaments under study; Availability and desire to observe the schedule of evaluations of the study; Agreement with and signing of the Term of Free and Informed Consent.

•Presence of clinical conditions related to malaria vivax that require hospitalization (coma, respiratory dysfunction or severe anemia); Presence of febrile conditions due to another disease besides malaria (for example, measles, acute infection of the respiratory tract, diarrhea with dehydration) or other chronic or severe comorbidities (for example, kidney, cardiac or chronic liver disease, and HIV/AIDS); Use of medicaments that can interfere in the pharmacokinetics of the antimalarial medicaments under study; Hypersensibility to the medicaments under study; History of the presence of deficiency of glucose-6-phosphate dehydrogenase; Any significant disease or clinical findings during the medical evaluation or physical examination that the investigator considers might interfere in the study; Pregnancy (confirmed by ? HCG) or breastfeeding; Use of antimalarial treatment less than 63 days prior to the symptoms.

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