ACTRN12613001187730已完成1 期
Characterisation of the in vivo infectivity of the Plasmodium falciparum 7G8 cell bank, MCB-004, in malaria naive adults.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •1)Volunteers will be males, aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the anti-malarial drug treatment).
- •2)Volunteers must have a BMI within the range 18–30.
- •3)Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
- •4)Be contactable and available for the duration of the trial (maximum of 90 days)
- •5)Volunteers must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
- •6)Good peripheral venous access.
排除标准
- •1)History of malaria.
- •2)Travelled to or lived (>2 weeks) in a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study.
- •3)Has evidence of increased cardiovascular disease risk (defined as >10%, 5 year risk) as determined by the method of Gaziano et al. Risk factors include sex, age, systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm2), reported diabetes status and blood pressure.
- •4)History of splenectomy.
- •5)History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination, infusion or treatment with the anti-malarial drugs artemether and/or lumefantrine.
- •6)Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma.
- •7)Known inherited genetic anomaly (known as cytogenetic disorders)e.g., Down’s syndrome.
- •8)Individuals wishing to donate blood to the Australian Red Cross Blood Service during the study or within 6 months of administration of the malaria inoculum.
- •9)The volunteer has a diagnosis of schizophrenia, severe depression, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. Participants who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating may be allowed to enroll in the study at the investigator’s discretion.
- •10)Known pre-existing prolongation of the QTc interval. Family history of congenital prolongation of the QTc interval on electrocardiograms or of sudden death or any other clinical condition known to prolong the QTc interval, e.g. volunteers with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
- •11)Recent or current therapy with an antibiotic or drug with potential anti-malarial activity (tetracycline, azithromycin, clindamycin, hydroxychloroquine etc).
- •12)Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine) OR drugs that are known to prolong the QTc interval, e.g. antiarrhythmics of classes IA and III, neuroleptics, antidepressant agents, certain antibiotics (including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents), certain nonsedating antihistamines (terfenadine, astemizole), cisapride.
- •13)Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants. Currently receiving or have previously received immunosuppressive therapy, including systemic steroids including ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression such as 1mg/kg/day of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids (budesonide 800 microgram per day or fluticasone 750 microgram).
- •14)Presence of acute infectious disease or fever (e.g., sub-lingual temperature greater than or equal to 38.5°C) within the five days prior to study product administration).
- •15)Evidence of acute illness wit
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