PACTR202012535210091尚未招募2 期
A Phase 2 interventional, multicenter, randomized, open-label study in three age-descending cohorts to evaluate efficacy, safety andtolerability of KAF156 and Lumefantrine-SDF combination, under fasted or fed conditions, in the treatment of acute uncomplicatedPlasmodium falciparum Malaria in a pediatric population
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 224
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
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •In Run-in Cohort: Male and female patients 12 to < 18 years of age, with a body weight = 35.0 kg
- •- In Cohort 1: Male and female patients 2 to < 12 years of age, with a body weight = 10.0 kg
- •- In Cohort 2: Male and female patients 6 months to < 2 years of age, with a body weight = 5.0 kg
- •- Microscopic confirmation of P. falciparum by Giemsa-stained thick and thin films
- •- P. falciparum parasitemia of = 1,000 and = 150,000 parasites/µL at the time of pre-screening
- •- Axillary temperature = 37.5 ºC or oral/tympanic/rectal temperature = 38.0 ºC; or history of fever during the previous 24 hours (at least documented verbally)
- •- The patient and his/her parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned
排除标准
- •- Mixed Plasmodium infections.
- •- Signs and symptoms of severe malaria
- •- Significant, nonplasmodial co-infections including tuberculosis
- •- Patients with concurrent febrile illnesses
- •- Known relevant liver disease
- •- Major congenital defects
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition 8. Immunosuppressive therapy within 3 months prior to
- •recruitment.
- •- Repeated vomiting or severe diarrhea
- •- Active duodenal ulcer, ulcerative colitis, Crohn’s disease, chronic use of non-steroidal anti-inflammatory drugs
- •- Clinically relevant abnormalities of electrolyte balance which require correction
- •- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the patient in case of participation in the study
- •- Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening
- •- Creatinine > 2 x ULN in the absence of dehydration. In case of dehydration, creatinine should be < 2 x ULN after oral/parenteral rehydration
- •- Known chronic underlying disease such as sickle cell disease, and severe cardiac, renal, or hepatic impairment
- •- Known active or uncontrolled thyroid disease
- •- History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval
- •- Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study
研究者
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