CAMPYLOBACTOR JEJUNI CHALLENGE MODEL DEVELOPMENT: DOSE-RANGING STUDY

空肠弯曲菌挑战模型开发：剂量范围研究

• 批准号: 7605828
• 负责人: Beth Diane Kirkpatrick
• 金额: $ 1.37万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605828
• 关键词: Antibiotics; Bacteria; Blood; Blood specimen; Campylobacter; Campylobacter infection; Campylobacter jejuni; Chemistry; Clinical assessments; Computer Retrieval of Information on Scientific Projects Database; Diarrhea; Disease; Documentation; Dose; Eligibility Determination; Enrollment; Feces; Female; Food; Funding; Goals; Grant; HIV; HLA-B27 Antigen; Hepatitis B Virus; Hepatitis C virus; Hour; Immunologics; Infection; Informed Consent; Ingestion; Inpatients; Institution; Medical History; Modeling; Outpatients; Pharmaceutical Preparations; Platelet Count measurement; Pregnancy Tests; Procedures; Range; Research; Research Personnel; Resources; Safety; Schedule; Screening procedure; Signs and Symptoms; Source; Specimen; Telephone; Testing; United States National Institutes of Health; Urine; Visit; Water; Weight; day; follow-up; model development; response; vaccine development; volunteer

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The reason for this research is to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The main goal in developing the model is to find a dose of the Campylobacter bacteria that causes diarrhea in about 3 out of 4 volunteers while being done as safely as possible. This information will assist the development of a vaccine against Campylobacter infections. Volunteers will be screened for eligibility within 60 days prior to enrollment. Screening will include obtaining signed informed consent prior to any study procedure. This will be followed by medical history, current medications, and blood samples for safety labs (WBC, HCT, HGB, platelet count; chemistry panel; screening for HIV, HLA-B27, HBV, and HCV; urine pregnancy testing for females). Eligible volunteers will be enrolled and admitted to the GCRC the night before, Day -1. Following challenge ingestion Day 0, the volunteers will have blood drawn to include safety labs and immunologic response, stool specimen collected, weight and tested, review of signs and symptoms, and clinical assessment. solicitation of AEs and documentation of concomitant medications will occur on all inpatient days, Day 0 to Day 9 and on scheduled study days, Day 14 and Day 28. All subjects will receive antibiotics and have two consecutive negative stool cultures within 12 hours to be eligible for discharge. Two outpatient follow up visits on Day 14 and Day 28 with blood drawn to include safety labs and immunologic response and There will be a 6 month phone assessment to check status of volunteers.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的原因是要开发一种用弯曲杆菌空肠杆菌（一种引起食物和水传播疾病的细菌（主要是腹泻））的感染模型。开发该模型的主要目的是找到一定剂量的弯曲杆菌细菌，该细菌在4个志愿者中约有3个，同时尽可能安全地进行腹泻。该信息将有助于开发针对弯曲杆菌感染的疫苗。 志愿者将在入学前60天内筛选资格。筛查将包括在任何学习程序之前获得已签署的知情同意书。随后将进行安全实验室的病史，当前药物和血液样本（WBC，HCT，HGB，血小板计数；化学面板；筛查HIV，HLA-B27，HBV和HCV；女性的尿液妊娠试验）。 符合条件的志愿者将在前一天晚上，第1天入选GCRC。挑战摄入第0天之后，志愿者将吸收血液以包括安全实验室和免疫反应，收集的粪便标本，体重和测试，体征和症状的审查以及临床评估。对AE的征集和随之而来的药物的文献将在所有住院时间，第9天到第9天以及预定的学习日，第14天和第28天。所有受试者都将接受抗生素，并在12个小时内有两次连续的负粪便培养物，可以符合出院资格。在第14天和第28天进行两次门诊后续访问，并抽血，包括安全实验室和免疫学反应，将进行6个月的电话评估以检查志愿者的状态。