PACTR202008909968293已完成2 期
Multi-Drug Combination-Therapies to Prevent the Development of Drug ResistancePhase II Controlled Clinical Trial Assessing Candidate Regimens of Multiple-Antimalarial Combinations for the Treatment of Uncomplicated Malaria in Africa
Bernhard Nocht Institute for Tropical Medicine0 个研究点目标入组 100 人开始时间: 2020年2月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- 2 Year(s) 至 5 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patient age >6 months <66 years
- •- Body weight >5 kg <90 kg
- •- Presence of mono-infection of P. falciparum with Fever, as defined by axillary temperature = 37.5°C or
- •oral/rectal/tympanic temperature = 38°C, or history of fever in the previous 24 hours and Microscopically confirmed parasite infection, in range 1,000 to 100,000 asexual parasites /µL of blood.
- •- Written informed consent provided by the adult patient, or parent or legally acceptable representative (LAR) of the minor patient or by an impartial witness (if the patient or patient’s LAR is illiterate), stating that the information has been read and/or is understood, and by the medically qualified Investigator. Children will be asked to provide assent where appropriate. The age from which this will be sought will be defined by local legislation.
排除标准
- •- Presence of severe malaria (according to WHO definition – WHO 2013)
- •- Anti-malarial treatment in the last 6 weeks.
- •- Known history or evidence of clinically significant disorders such as, cardiovascular, respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma).
- •- Mixed Plasmodium infection
- •- Severe vomiting, defined as more than three times in the 24 hours prior to enrolment in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day
- •- Severe malnutrition (defined for subjects aged ten years or less as the weight-for- height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalised reference values, and for subjects aged greater than ten years, a body mass index (BMI) of less than 16 (WFP Manual, Chapter 1)).
- •- Known history of hypersensitivity, allergic or adverse reactions to any of the study drugs
- •- Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
- •- Haemoglobin level below 8 g/dL.
- •- Serum creatinine levels =2 x ULN
- •- Female patients of child bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures not to become pregnant during the study period and safety follow-up period.
- •- Have received an investigational drug within the past 4 weeks.
- •- Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance.
- •- Refusal to participate and to provide written or witnessed informed consent or assent.
研究者
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