An Observational Study in Adults With Clostridioides Difficile Infection to Determine the Feasibility and Logistics of Biospecimen Collection, Transportation and Testing at Select US Study Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of participants that completed key study activities according to protocol
研究概览
简要总结
D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires
详细描述
The premise of D8820C00001 study is to monitor participants for recurring episodes of diarrhea and evaluate acceptability and feasibility of the use of the digital tools and patient outcome measures. The aim will be to enroll two cohorts of patients; the first will be the Monitoring cohort, enrolling a targeted minimum of 20 and a maximum of 100 participants who will be followed through Day 42, with a screening period from start of standard of care treatment to Day 1 (see Section 2.1.1). The second will be the Discard Stool cohort, enrolling up to 200 participants, who will not be followed during the study but who will provide consent for the use of any discarded stool specimens that will not be used for additional laboratory diagnostic testing .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥ 18 years of age at the time of signing the informed consent
- •Participants in the Monitoring and Discard Stool cohorts with an active treated CDI, defined as meeting all of the following:
- •Prior to or at diagnosis of C. difficile, either diarrhea, defined as ≥ 3 unformed stools in a 24 hour period, with the stool being measured as Types 5, 6, 7 on the Bristol Stool Scale or evidence of megacolon, or severe ileus.
- •A positive local stool test results for toxigenic C difficile collected before entry to the study or evidence of pseudomembranes demonstrated by endoscopy or histopathology.
- •For the Monitoring Cohort - positive test result immediately prior to start of or during SOC treatment.
- •For the Discard Stool Cohort - no more than 7 days prior to entry to the study.
- •Stool test positive for only GDH or PCR and negative for toxin, provided there is observed clinical improvement noted by the Investigator within 5 days of start of SOC treatment, characterized by a reduction in diarrhea , in the the judgement of the Investigator
- •Receiving SOC therapy for the treatment of CDI at the time of enrollment.
- •Able to complete all study assessments, and to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative, or equivalent representative as locally defined) based on the assessment of the PI
- •Able to complete the Follow-up period through Day 42 based on the assessment of the PI.
- •If able, signed and dated written informed consent prior to any study specific procedures, including screening evaluations for participants who consent to participate in the Monitoring cohort. Ensure that participants who are considered by the Investigator clinically unable to consent at screening and who are entered into the study by the consent of a legally acceptable representative show evidence of assent, as applicable in accordance with local regulations.
- •Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort
排除标准
- •Employees of AstraZeneca, clinical study site, or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals. Employees of the clinical site or immediate families of these individuals not directly involved in the clinical study will be permitted to participate.
- •Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily
- •Absence of suitable venous access for serum sampling
结局指标
主要结局
Number of participants that completed key study activities according to protocol
时间窗: from Day 1 to Day 42
Evaluation of the overall and individual completion rate of procedures and logistics involved in key study activities defined as: * Stool sample collection, transport, and processing. * Serum collection. * Identification of suspected rCDI using the participant monitoring strategy * Cdiff32, CDI-DaySyms and PGI-S PRO questionnaire completion rate during the SOC treatment period.
次要结局
- Participant Experience and site staff evaluation questionnaires(from Day 1 to Day 42)
- Time intervals across stool sample collection logistics(from Day 1 to Day 42)
- Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA)(from Day 1 to Day 42)