PACTR202004535453508招募中2 期
A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether-lumefantrine (2.5 mg:30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
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
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- All
入选标准
- •1. Male or female neonates / infants
- •2. Body weight <5 kg but = 2kg
- •3. In Cohort 1, infants aged >28 days; in Cohort 2, neonates aged 1 to =28 days (3 subgroups: 15-28 days; 8-14 days; 1-7 days)
- •4. Microscopically confirmed diagnosis of P. falciparum malaria (or mixed infections)
- •in Cohort 1: of =500 and <100,000 parasites/µL asexual P. falciparum parasitemia
- •in Cohort 2: of =100 and <100,000 parasites/µL asexual P. falciparum parasitemia
- •either congenital or neonatal
- •either symptomatic or asymptomatic
排除标准
- •1. Head circumference < - 2 SD z-score in cm following WHO age and sex-specific reference curves (suspicion of microcephaly)
- •2. Severe malnutrition
- •3. Presence of severe malaria (according to WHO 2015 definition)
- •4. HIV status:
- •in Cohort 1 : patient’s or patient's mother's current treatment with ARV
- •in Cohort 2 : Mother’s known HIV positive status at patient's birth or mother's current treatment with ARV
- •5. Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants, WHO 2005)
- •6. Presence of any clinically significant neurological condition:
- •any episode of convulsion during the present illness (in keeping with the IMCI list of general danger signs)
- •known neurological disorders (e.g. chronic seizure disorders, cerebral palsy)
- •7. Presence of clinically significant abnormality of the hepatic and renal systems
- •8. History of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could affect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion
- •9. Known hypersensitivity of the patient or either patient's parent to artemether, lumefantrine, any of the excipients of Coartem®/Riamet® Dispersible tablet, or to drugs of similar chemical classes
- •10. Known family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
- •11. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
- •12. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
研究者
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