CTRI/2024/06/068890招募中3 期
A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children with more than or equal to 5 kg body weight followed by an Extension phase with repeated KLU156 treatment
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia = 1,000 and = 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection.
- •2. Axillary temperature = 37.5 ºC or oral temperature = 38.0 ºC or tympanic/rectal temperature = 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)
- •3. Negative pregnancy test for patients of childbearing potential
- •4.Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards
- •5. The patient and/or their 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
- •1.Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)
- •2.Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)
- •3.Severe malnutrition. For patients = 12 years: body mass index (BMI) < 16.0. For children < 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC < 115 mm)
- •4.Repeated vomiting (defined as > 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as > 3 watery stools in the 24 hours prior to start of screening)
- •5.Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia
- •6.Anemia (hemoglobin level <7 g/dL)
- •7.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may jeopardize the patient in case of participation in the study.
- •8.Any of the following:
- •Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) > 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin
- •Total bilirubin > 3 x ULN
- •Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening
- •9.Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)
- •10.History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease
- •11.Pregnant or nursing (lactating) patients.
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