PACTR201311000659400已完成未知
Efficacy and safety of Artemisinin-based Combination Therapies (ACTs) in malaria-infected patients taking Antiretroviral Therapies (ART) in Malawi, Moçambique and Zambia.
iverpool School of Tropical Medicine0 个研究点目标入组 489 人开始时间: 2013年10月4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
- 489
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15 Year(s) 至 65 Year(s)（—）
- 性别
- All
入选标准
- •1.Age ¿15 to ¿65 years old
- •2.Female patients, if of child-bearing potential must not be pregnant and lactating
- •3.Body weight > 35 kg
- •4.Initial parasite densities not exceeding 200,000/µL.
- •5.Presence of fever (axillary temperature ¿ 37.5 °C or oral ¿ 38 °C) or a history of fever or malaria-like symptoms (nausea, vomiting, myalgia or arthralgia) in the past 24 hours
- •6.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is <18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age.
- •7.Willingness and ability to comply with scheduled visits, supervised treatment administration, laboratory tests, and other study procedures.
- •8.Ability to swallow oral medications.
排除标准
- •1.Patients with severe malaria as per WHO criteria.
- •2.Patients with mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae).
- •3.Hemoglobin (Hb) level of < 7 gm/dL.
- •4.A female patient who is lactating or pregnant at screening.
- •5.Use any antimalarial treatment and other drugs with antimalarial activity except cotrimoxazole 1 month prior to the screening
- •6.Known allergy to any of the components or by-products of the ACT which is being used in the clinical trial. This may include artesunate, artemether, artemisinin-derived products, lumefantrine, piperaquine, or amodiaquine.
- •7.Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as > 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening).
- •8.Participation in any investigational drug trial during the 30 days prior to screening.
- •9.Evidence of clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, neurological, psychiatric or endocrine diseases or other abnormalities (other than malaria) that may increase the risk associated with study participation
- •10.Clinical symptoms of febrile conditions due to diseases other than malaria (eg measles, acute respiratory tract infections) that may compromise the evaluation of the response to the study medication.
- •11.Patients who have had a splenectomy as confirmed by history or clinical examination.
- •12.Patients with a history of epilepsy or convulsions.
- •13.Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
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