NL-OMON37044已完成不适用
Comparison of three Plasmodium falciparum isolates in a controlled human malaria infection - TIP3
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 18 至 99（—）
入选标准
- •1. Males and females aged 18-35 years
- •2. In general good health based on history, physical examination and basic haematology and biochemistry
- •3. Negative pregnancy test for females
- •4. Use of adequate contraception for females
- •5. Signed informed consent, based on a thorough understanding of the concept and procedures of the study
- •6. Volunteer agrees to allow informing his/her general practitioner about participation and agrees to sign a request for medical information from the GP concerning any contra-indications for participation in the study
- •7. Willingness to undergo a Pf sporozoite challenge
- •8. Agreement to stay in a hotel close to the trial center during part of the study (day 5 until three days post-treatment)
- •9. Reachable (24/7) by mobile telephone during the whole study period
- •10. Available to attend all study visits
- •11. Agreement to refrain from blood donation to Sanquin or for other purposes, during the course of the study and thereafter following Sanquin guidelines.
- •12. Willingness to undergo an HIV, HBV and HCV screening test
- •13. Negative urine toxicology screening test at the screening visit and on the day before challenge
- •14. Willingness to take a curative regimen of Malarone®
排除标准
- •1. History of malaria
- •2. Plans to travel outside of the Netherlands during the study period
- •3. Previous participation in any malaria vaccine study and/or positive serology for P. falciparum
- •4. Symptoms, physical signs or laboratory values suggestive of systemic disorders, including but not limited to renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results
- •5. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- •6. Clinically significant ECG abnormalities at screening, or history of arrhythmia*s or prolonged QT-interval
- •7. Positive family history of cardiac disease in 1st or 2nd degree relatives < 50 years old
- •8. An estimated ten year risk of fatal cardiovascular disease of >=5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
- •9. Body Mass Index (BMI) below 18 or above 30 kg/m2
- •10. Any clinically significant deviation from the normal range in haematological or biochemical blood tests or urine analysis
- •11. Positive HIV, HBV or HCV screening tests
- •12. Participation in any other clinical study within 30 days prior to the onset of the study or during the study period
- •13. Pregnant or lactating women
- •14. Volunteers unable to give written informed consent
- •15. Volunteers unable to be closely followed during the study period for social, geographic or psychological reasons
- •16. Previous history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset
- •17. A history of psychiatric disease or convulsions
- •18. Known hypersensitivity to anti-malarial drugs
- •19. History of severe reactions or allergy to mosquito bites
- •20. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids are allowed) or during the study period
- •21. Contra-indications for Malarone® use, including treatment taken by the volunteers that interferes with Malarone®
- •22. Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- •23. Co-workers of the departments of Medical Microbiology of the UMC St Radboud, the department of Internal Medicine of the Havenziekenhuis or the department of Medical Microbiology & Infectious Diseases of the Erasmus MC
- •24. A history of sickle cell, thalasaemia trait or G6PD deficiency ;For sub-study Odour profile additionally:
- •25. Smokers
- •26. Regular medicine use
研究者
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