Efficacy of artemether-lumefantrine and dihydroartemisinin – piperaquine for treatment of uncomplicated malaria in children in Uganda

ganda Ministry of Health0 个研究点目标入组 599 人开始时间: 2015年10月20日最近更新: 2020年2月3日

适应症

试验速览

2019 results in ncbi.nlm.nih.gov/pubmed/30418593 (added 14/01/2020)

•1. Age 6 – 59 months
•2. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
•3. Ability to participate in 42-day follow-up (patient has easy access to health unit)

•1. Weight < 5 kg
•2. History of serious side effects to study medications
•3. Concomitant febrile illness or 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
•4. Treatment with antimalarial drugs (ACTs) already started and ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women.
•5. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference)
•6. Danger signs or evidence of severe malaria:
•6.1. Unarousable coma (if after convulsion, > 30 min)
•6.2. Recent convulsions (1-2 within 24 h)
•6.3. Altered consciousness (confusion, delirium, psychosis, coma)
•6.4. Lethargy
•6.5. Unable to drink or breast feed
•6.6. Vomiting everything
•6.7. Unable to stand/sit due to weakness
•6.8. Severe anemia (Hb < 5.0 gm/dL)
•6.9. Respiratory distress (labored breathing at rest)
•6.10. Jaundice
•7. 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 < 110 mm).
•8. Regular medication, which may interfere with antimalarial pharmacokinetic
•9. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)

发起方

ganda Ministry of Health