C.Difficile Observational Study (NCT06277999) | Clinical Trial Compass
CompletedNot Applicable
C.Difficile Observational Study
United States7 participantsStarted 2024-04-22
Plain-language summary
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 ā„ 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
Who can participate
Age range18 Years ā 130 Years
SexALL
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Inclusion criteria
ā. Male or female participants ā„ 18 years of age at the time of signing the informed consent
ā. Participants in the Monitoring and Discard Stool cohorts with an active treated CDI, defined as meeting all of the following:
ā. 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
ā. Able to complete the Follow-up period through Day 42 based on the assessment of the PI.
ā. 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.
ā. Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort
Exclusion criteria
ā. 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.
ā. Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily
What they're measuring
1
Number of participants that completed key study activities according to protocol