A Serological Study in Adult Subjects With Clostridium Difficile Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 6
- 主要终点
- Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14
研究概览
简要总结
This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
详细描述
Patients with an initial episode of CDI will be followed up for CDI recurrence or sustained clinical response. The subjects will be allocated into 2 groups at the study end:
- Recurrence Group: Subjects who experience recurrence of CDI after clinical response to antibiotic treatment to treat the initial CDI episode.
- Sustained response Group: Subjects who do not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
This protocol has been amended twice to improve recruitment of subjects in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol or/ and subjects who can receive assistance from his/ her legally acceptable representative (LAR) or a designate who can and will comply with the requirements of the protocol.
- •A male or female aged 18 years or older at the time of enrolment.
- •Written informed consent obtained from the subject/ LAR of the subject.
- •A reasonable prognosis of survival during the study period as judged by the investigator.
- •Outpatients, emergency room and/ or hospitalized subjects diagnosed with CDI for which the symptoms started maximum 14 days prior to study enrolment.
- •Subjects who receive or plan to receive antibiotic treatment to treat the CDI episode.
排除标准
- •Concurrently participating or planning to participate in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •Previous CDI episode within the previous 6 months before study enrolment (except for up to ~25% of the subjects).
- •Chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease.
- •Planned surgery for CDI within 24 hours after study entry.
- •Previous vaccination against Clostridium difficile.
- •Having received a Clostridium difficile monoclonal antibody product(s) within the previous 3 months or planned administration during the study period.
- •Administration of immunoglobulins within the previous 3 months or planned administration during the study period.
- •Subject having any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the subject participating in the study, would make it unlikely for the subject to complete the study, or would confound the results of the study.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within the previous 6 months.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects.
研究组 & 干预措施
Recurrence group
Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
干预措施: Blood sampling (Procedure)
Recurrence group
Male or female subjects aged 18 years or older at the time of enrollment, who experienced recurrence of Clostridium difficile infection (CDI) after clinical response to antibiotic treatment to treat the initial CDI episode.
干预措施: Stool sample collection (Other)
Sustained response group
Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
干预措施: Blood sampling (Procedure)
Sustained response group
Male or female subjects aged 18 years or older at the time of enrollment, who did not experience recurrence of CDI after clinical response to the antibiotic treatment to treat the initial CDI episode.
干预措施: Stool sample collection (Other)
Failure to antibiotic Group
Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
干预措施: Blood sampling (Procedure)
Failure to antibiotic Group
Male or female subjects aged 18 years or older at the time of enrollment, withdrawn due to failure of antibiotic treatment to treat the initial CDI episode.
干预措施: Stool sample collection (Other)
Unclassified Group
Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
干预措施: Blood sampling (Procedure)
Unclassified Group
Male or female subjects aged 18 years or older at the time of enrollment, who couldn't be classified as sustained response, recurrence, or failure to antibiotic due to missing data.
干预措施: Stool sample collection (Other)
结局指标
主要结局
Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14
时间窗: At Day 14
Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL.
Serum F2 C-terminal Anti-toxin B Antibody Concentrations
时间窗: At Day 14
Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL.
次要结局
- Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72(At Day 0 and at Day 72)
- Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14(At Day 14)
- Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 0, Within 10 Days After Recurrence and at Day 72(At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (Day 72))
- Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence(From Day 0 to Day 72)
- CDI Initial Episodes Severity Characteristics, in All Subjects(At Day 0)
- Number of Subjects With Initial CDI Episode by Severity, in All Subjects(At Day 0)
- Number of Subjects With CDI Recurrence by Severity, in Those Subjects Who Recur(At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant)
- Number of Subjects With Failure of Antibiotic Treatment(Within 3 months before the initial CDI episodes)
- Number of Subjects With Risk Factors Associated With the Initial CDI Episode(At Day 0)
- Number of Subjects With Risk Factors Associated With the CDI Recurrence(At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant)