Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7 participants
OBSERVATIONAL
2024-04-22
2024-12-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Monitoring Cohort
Monitoring cohort will enroll a targeted minimum of 20 and a maximum of 100 participants ≥ 18 years of age who have been recently diagnosed with CDI by a licensed HCP and are receiving SOC antibiotic treatment, with treatment starting ≤ 5 days before study enrollment. Participants will be recruited from hospitals which perform C difficile laboratory diagnostic testing. Recruitment will occur over a 6-month period. Participants will be followed through Day 42, with a screening period from Day -5 to Day 1
No interventions assigned to this group
Discard Stool Cohort
The Discard Stool cohort will include stool specimens from up to 200 participants, ≥ 18 years of age, who have been recently diagnosed with CDI by a licensed HCP within the past 7 days. Participants in this cohort will be screened at the study site to confirm eligibility. Following the screening period, there will be no additional study activities for the participant to complete.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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
4. Able to complete the Follow-up period through Day 42 based on the assessment of the PI.
5. 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.
6. Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort
Exclusion Criteria
2. Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily
3. Absence of suitable venous access for serum sampling
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Sacramento, California, United States
Research Site
Hamden, Connecticut, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Charleston, South Carolina, United States
Research Site
Charlottesville, Virginia, United States
Countries
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Related Links
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Other Identifiers
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D8820C00001
Identifier Type: -
Identifier Source: org_study_id