PACTR202303470809477尚未招募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 = 5 kg body weight followed by an Extension phase with repeated KLU156 treatment
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,500
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
- •Core Phase:
- •1. Male or female patients = 5 kg of body weight and = 2 months of age
- •2. 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.
- •3. 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 h (at least documented verbally)
- •4. Negative pregnancy test for patients of childbearing potential
- •5. Signed informed consent (pre-screening and screening for the Core phase) must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian (LAR). If the parent/LAR 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 parental/LAR consent or as per local ethical standards
- •6. The patient and/or their parent/LAR is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.
- •Extension Phase:
- •1. Patients randomized into the Core phase and having completed it.
- •2. Signed informed consent (for the Extension phase) must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/LAR. If the parent/LAR 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 assent with parental/legal guardian consent or as per local ethical guidelines.
排除标准
- •Core Phase:
- •1. Signs and symptoms of severe malaria according to WHO 2015
- •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 h prior to start of screening) or severe diarrhea (defined as >3 watery stools in the 24 h 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., HIV patients on ART therapy or TB patients on treatment), or which may jeopardize the patient in case of participation in the study.
- •8. Any of the following:
- •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
- •Extension Phase:
- •Patients meeting the following criteria in the Core phase are not eligible for transition into the Extension phase:
- •Early Treatment Failure (KLU156 or Coartem treatment arm)
- •Patients with reported study treatment-related SAE (KLU156 or Coartem).
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