The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 24
- 主要终点
- Genetic identification of the rickettsia species
研究概览
简要总结
The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsioses in biological samples of patients from the regions of Russia. This is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. During the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. The rests of the samples used for standard diagnostics (blood, plasma, buffy coat, or serum, and/or swab of the eschar) are being collected and afterwards analyzed for rickettsial genotypes. These data are being compared to the medical history and symptoms of the patients in order to identify clinical patterns specific for causative agents of rickettsioses. Informed consent from all patients or their legal representatives are being collecting. The study was approved by the ethical committee.
详细描述
This is an observational study with no intervention by the Sponsor or CRO in routine treatment or diagnostic process. Patient treatment strategy is not influenced by the study protocol or by the physician's intention to include the patient in the study; instead, is based on current standards of medical care for patients with rickettsioses.
The researcher (practicing physician) are being required to obtain written informed consent form (ICF) from each patient prior to inclusion. Biological sample collection are carried out using residual samples from standard diagnostics of patients who have signed an informed consent agreement. The researcher (practicing physician) start complete an individual case report form (CRF) for each patient who signed informed consent and whose biological samples have been collected.
Prior to the commencement of the study, the sponsor obtained approval from the ethics committee to conduct the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, the subject must meet all the following criteria:
- •Written informed consent by the subject (or their legal representative) to participate in the study;
- •Men and women of any age, including children, who:
- •have sought medical care (outpatient or inpatient) with suspected or diagnosed rickettsiosis; or have sought medical care (inpatient) with a history of tick bites and elevated body temperature (at least 37.2 °C lasting at least 48 hours).
排除标准
- •- Inability or unwillingness of the subject (or their legal representative) to participate in the study
结局指标
主要结局
Genetic identification of the rickettsia species
时间窗: up to 4 weeks
Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes
次要结局
未报告次要终点