Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children

Institute Tropical Medicine0 个研究点目标入组 0 人开始时间: 2008年11月10日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1. Weight > 5 kg;
•2. Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 asexual parasites per µl;
•3. Fever (axillary temperature ³37.5 °C) or history of fever in the preceding 24 hours;
•4. Haemoglobin value more or equal to 7.0 g/dl;
•5. Signed informed consent by the parents or guardians;
•6. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial

•1. Participation in any other investigational drug study (antimalarial
•or others) during the previous 30 days
•2. Known hypersensitivity to the study drugs
•3. Severe malaria
•4. Danger signs: not able to drink or breast-feed, vomiting (> twice in
•24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
•5. Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency
•6. Severe malnutrition (defined as weight for height <70% of the median
•NCHS/WHO reference)
•7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women

发起方

Institute Tropical Medicine