NL-OMON54881已完成不适用
Establishing a Female-only Controlled Human Schistosoma mansoni Infection Model: a safety and dose finding study (CoHSI2) - CoHSI2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
Trial ended prematurely
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. Subject is aged >= 18 and <= 45 years and in good health.
- •2. Subject has adequate understanding of the procedures of the study and agrees
- •to abide strictly thereby.
- •3. Subject is able to communicate well with the investigator, is available to
- •attend all study visits.
- •4. Subject will remain within Europe (excluding Corsica) during the study
- •period and is reachable by mobile telephone from week 3 to week 8 of the study
- •5. Subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period.
- •6. For female subjects: subject agrees to use adequate contraception and not to
- •breastfeed for the duration of study.
- •7. Subject has signed informed consent.
排除标准
- •1. Any history, or evidence at screening, of clinically significant symptoms,
- •physical signs or abnormal laboratory values suggestive of systemic conditions,
- •such as cardiovascular, pulmonary, renal, hepatic, neurological,
- •dermatological, endocrine, malignant, haematological, infectious,
- •immune-deficient, psychiatric and other disorders, which could compromise the
- •health of the volunteer during the study or interfere with the interpretation
- •of the study results. These include, but are not limited to, any of the
- •- body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening;
- •- positive HIV, HBV or HCV screening tests;
- •- the use of immune modifying drugs within three months prior to study onset
- •(inhaled and topical corticosteroids and oral anti-histamines exempted) or
- •expected use of such during the study period;
- •- history of malignancy of any organ system (other than localized basal cell
- •carcinoma of the skin), treated or untreated, within the past 5 years;
- •- any history of treatment for severe psychiatric disease by a psychiatrist in
- •the past year;
- •- history of drug or alcohol abuse interfering with normal social function in
- •the period of one year prior to study onset.
- •2. The chronic use of any drug known to interact with praziquantel, artesunate
- •or lumefantrine metabolism (e.g. phenytoïn, carbamazepine, phenobarbital,
- •primidon, dexamethason, rifampicine, cimetidine, flecaïnide, metoprolol,
- •imipramine, amitriptyline, clomipramine, class IA and III anti-arrythmics,
- •antipsychotics, antidepressants, macrolides, fluorchinolones, imidazole- and
- •triazole antimycotics, antihistamines) Because lumefantrine may cause extension
- •of QT-time, chronic use of drugs with effect on QT interval are excluded from
- •3. For female subjects: positive urine pregnancy test at screening.
- •4. Any history of schistosomiasis or treatment for schistosomiasis.
- •5. Positive serology for schistosomiasis or elevated serum CAA at screening.
- •6. Known hypersensitivity to or contra-indications (including co-medication)
- •for use of praziquantel, artesunate or lumefantrine.
- •7. Being an employee or student of the department of parasitology or infectious
- •diseases of the LUMC
研究者
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