An experimental study to characterize the effectiveness of Lariam(Registered Trademark) (Mefloquine) against early Plasmodium falciparum blood stage infection in healthy volunteers.

The Queensland Institute of Medical Research0 个研究点目标入组 24 人开始时间: 2012年3月21日最近更新: 2020年1月13日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 24

研究概览研究设计入排标准研究者记录与标识符相似试验

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: All

入选标准

•1. Volunteers will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial 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 4 weeks).
•5. Volunteers must be non-smokers and in good health, as assessed during pre-study medical examination and by review of screening results.
•6. Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
•7. 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 or infusion.
•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) Volunteers wishing to be able to donate blood to the ARCBS in the future
•9) Presence of retinal or visual field changes either attributable to 4-aminoquinoline compounds or to any other etiology
•10) The volunteer has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis
•11) The volunteer has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others
•12) The volunteer is receiving psychiatric drugs. 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.
•13) Known pre-existing prolongation of the QTc interval
•14) 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
•15) Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.)
•16) Known hypersensitivity to sulfa drugs
•17) 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.
•18) 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

研究者

发起方

The Queensland Institute of Medical Research

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