Thiamin treatment and Plasmodium falciparum malaria in Laos

niversity of Oxford (UK)0 个研究点目标入组 814 人开始时间: 2008年1月23日最近更新: 2015年1月13日

适应症

试验速览

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•1. Written fully informed consent given by patients and in the case of children, by parents or guardians
•2. Males and females of any age
•3. Microscopically confirmed Plasmodium falciparum infection with history of fever. Multiple Plasmodium species infections will be included.
•4. Willingness and ability to comply with the study protocol for the duration of the 42 days follow up
•5. Did not take a full course of any antimalarial drugs in previous three days

•1. Known hypersensitivity to thiamin
•2. Presence of intercurrent non-malarial illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
•3. Clinically apparent suspected thiamin deficiency (beriberi), which will be defined (World Health Organization [WHO] 1999) as:
•3.1. Children less than 5 years: peripheral oedema or clinical evidence for pulmonary oedema, or cyanosis or classical hoarse cry
•3.2. Adults and children greater than 5 years: peripheral oedema or clinical evidence for pulmonary oedema or lower limb paraesthesia or, before malarial illness, difficulty in rising from squatting position (it will be difficult to distinguish features of wet beriberi, such as peripheral and pulmonary oedema, from consequences of malaria, such as severe anaemia, acute respiratory distress syndrome [ARDS] and pneumonia. Clinicians will be cautious and classify the patient as having beriberi if there is doubt).

发起方

niversity of Oxford (UK)