ISRCTN12174271进行中（未招募）未知
Controlled Human Malaria Infection models for evaluation of Plasmodium falciparum transmission-blocking interventions in healthy Malian adults
niversité des Sciences, des Techniques et des Technologies de Bamako0 个研究点目标入组 42 人开始时间: 2022年3月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- 性别
- Male
入选标准
- •1. Males aged =18 and =50 years and in general good health.
- •2. Known long-term resident (more than 1 year) of Sotuba or surrounding area.
- •3. Participant has adequate understanding of the procedures of the study and is able and willing (in the investigator’s opinion) to comply with all study requirements, including, but not limited to:
- •3.1. remaining in Sotuba during the challenge period, not travelling during the study period, and remaining reachable (24/7) by mobile telephone throughout the entire study period
- •3.2. available to attend all study visits, and willing to sleep in appropriate accommodation close to the trial center during part of the study (from day 5 post-infection until either (i) end of study, or (ii) day 28 if parasitemia does not develop before this time
- •3.3. refraining from blood donation throughout the study period and for a 6 week period thereafter
- •4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrolment process.
- •5. Willing to have blood samples stored for future research.
- •6. The participant has correctly answered =80% of the questions on the Study Comprehension Exam.
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, immunodeficient, psychiatric and other disorders, which could compromise the health of the participant during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following.
- •1.1. Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening.
- •1.2. History, or evidence at screening, of elevated risk for cardiovascular disease, including arrhythmia or clinically relevant bradycardia, prolonged QT-interval (>450ms) or other relevant ECG abnormalities; a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old, or of sudden (cardiac) death.
- •1.3. Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years
- •1.4. History of a severe allergic reaction or anaphylaxis
- •1.5. Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren’s syndrome, or autoimmune thrombocytopenia
- •1.6. A medical history of functional asplenia, sickle cell disease, thalassaemia trait/disease or G6PD-deficiency.
- •1.7. History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
- •1.8. Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- •1.9. Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet, alanine transaminase (ALT) or creatinine (Cr) levels outside the local laboratory–defined limits of normal. (Subjects may be included at the investigator’s discretion for not clinically significant” values outside of normal range and = Grade 2.
- •1.10. Chronic use of immunosuppressive or other immune modifying drugs within three months prior to study onset (inhaled, intranasal and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
- •1.11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- •1.12. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
- •1.13. Suspicion of alcohol or illicit drug abuse interfering with health or normal occupational or social function in the period of one year prior to study onset.
- •2. Any recent or current systemic therapy with an antibiotic or drug with potential anti-malarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.; allowable timeframe for use at the Investigator’s discretion).
- •3. Previous receipt of any malar
研究者
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