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
Sponsor study identifier
observational
7
1 country
7
Study Start
April 22, 2024
Actual (reported)Primary Completion
December 17, 2024
Actual (reported)Study Completion
December 17, 2024
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 17, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2024
Actual (reported)February 26, 2024
Actual (reported)April 22, 2024
Actual (reported)December 17, 2024
Actual (reported)December 17, 2024
Actual (reported)Number of participants that completed key study activities according to protocol
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.
from Day 1 to Day 42
Time intervals across stool sample collection logistics
from Day 1 to Day 42
Participant Experience and site staff evaluation questionnaires
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
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
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.
≥ 18 Years of Age (Adult, Older Adult )
Research Site
Sacramento, California, 95817, United States
Research Site
Hamden, Connecticut, 06518, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Charlottesville, Virginia, 22903, United States
stool, serum samples
7 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2024
First Posted
February 26, 2024
Study Start
April 22, 2024
Actual (reported)Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
Contact the study team to confirm eligibility.
Primary Completion
December 17, 2024
Actual (reported)Study Completion
December 17, 2024
Actual (reported)Last Updated
December 19, 2025
Record last verified: 2025-12
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Source: ClinicalTrials.gov.
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