ISRCTN94367569已完成未知
Treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso: comparison of artemether/lumefantrine, dihydroartemisinin/piperaquine, and amodiaquine/sulfadoxine-pyrimethamine
Institut de Recherche en Science de la Sante (IRSS) (Burkina Faso)0 个研究点目标入组 528 人开始时间: 2007年4月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 528
研究概览
简要总结
2007 Results article in https://doi.org/10.1086/522985 (added 23/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 6 months and above
- •2. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
- •3. Absence of any history of serious side effects to study medications, including allergy to sulfa drugs
- •4. No evidence of a concomitant febrile illness in addition to malaria
- •5. Provision of informed consent and ability to participate in 42-day follow-up (patient has easy access to health unit)
- •6. No history of treatment with any antimalarial (other than chloroquine) in the past 2 weeks.
- •7. No danger signs or evidence of severe malaria defined as:
- •7.1 Unarousable coma (if after convulsion, > 30 min)
- •7.2 Repeated convulsions (> 2 within 24 h)
- •7.3 Recent convulsions (1-2 within 24 h)
- •7.4 Altered consciousness (confusion, delirium, psychosis, coma)
- •7.5 Lethargy
- •7.6 Unable to drink or breast feed
- •7.7 Vomiting everything
- •7.8 Unable to stand/sit due to weakness
- •7.9 Severe anemia (hemoglobin < 5.0 g/dL)
- •7.10 Respiratory distress (labored breathing at rest)
- •7.11 Jaundice (yellow coloring of eyes)
- •Patients fulfilling these criteria will be assigned a study number and referred to the study nurse for treatment allocation and treatment with the study medications. Patients must also meet the following criterion:
- •8. Absence of repeated vomiting of study medications on day 0
- •After treatment with the study medications, patients will be referred to the laboratory. A fingerprick blood sample will be obtained to prepare thick and thin blood smears, and for measurement of hemoglobin. Patients will be excluded from the study on day 1 if the following inclusion criteria are not met.
- •9. P. falciparum mono-infection
- •10. Parasite density > 2000/ul and < 200,000/ul
- •11. Hemoglobin > 5.0 g/dL
排除标准
- •1. Signs of severe malaria/danger signs
- •2. Known Allergy to the study medications
- •3. Inability to participate in 42 days follow up
- •4. Concommittant febrile illness
- •5. Severe anemia < 5g/dL
- •6. Absence of provision of informed and signed consent
- •7. Previous antimalarial use (other than chloroquine [CQ]) in the previous 14 days
- •8. Mixed infection
研究者
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