PACTR202206584817951已完成2 期
Efficacy and safety of Praziquantel for treatment of Plasmodium falciparum infection in asymptomatic Gabonese adults
未提供0 个研究点目标入组 44 人开始时间: 2022年3月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Subject male or female with age = 18 years
- •Plasmodium parasitaemia with 200 to 5000 parasites/µL
- •Asymptomatic malaria defined by: presence of Plasmodium parasites with absence of fever (axillary temperature = 37.5 ° C or oral / tympanic temperature = 38 ° C, or absence of history of fever in recent 24 hours and the week before inclusion).
- •Signed and written informed consent
- •Willingness not to take drugs or substances which could have an impact on praziquantel blood levels
- •Women only: Must agree to practice continuous contraception for the duration of the study. Those methods include: combined (estrogen and progestogen containing) hormonal contraception, associated with inhibition of ovulation, oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation, oral, injectable, implantable intrauterine device (IUD), intrauterine hormonereleasingsystem (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence and use of condoms.
排除标准
- •Signs and symptoms of complicated malaria / severe malaria
- •Taking an experimental drug in the last 4 weeks.
- •Any antimalarial treatment in the last 4 weeks
- •Is using and intends to continuing using a medication known to cause drug reactions with artemether/lumefantrine (e.g. cimetidine, metoclopramide, antacids, kaolin, terfenadine etc.)
- •Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin).
- •Use of praziquantel within 30 days of study enrolment.
- •Previous (within the last 10 years) participation in a malaria vaccine study
- •Moderate to severe anemia (Hemoglobin level < 8 g/dL)
- •Known history of hepatic disease or liver damage
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •Use of immunoglobulins or blood products within 3 months prior to enrolment
- •Contraindications or known allergy to praziquantel or the first-line anti-malarial medication artemether/lumefantrine, or known or suspected allergy or intolerance to any other ingredient of the drug products (IMP/Non-IMP)
- •Severe malnutrition (Body Mass Index (BMI) < 16.0)
- •Pregnancy, lactation or intention to become pregnant during the study
- •Known history of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait
- •Participants unable to be closely followed for social, geographic or psychological reasons
研究者
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