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
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 .
Study Type
OBSERVATIONAL
Enrollment
7
Research Site
Sacramento, California, United States
Research Site
Hamden, Connecticut, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
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.
Time frame: from Day 1 to Day 42
Time intervals across stool sample collection logistics
All stools counted regardless of multiple stools per participant: * selected percentiles of empirical distribution of time taken for samples to be collected by courier for transport to central lab (split by geography, site, or home) * selected percentiles of empirical distribution of time taken of testing procedure or components thereof
Time frame: from Day 1 to Day 42
Participant Experience and site staff evaluation questionnaires
Review of Participant Experience and site staff evaluation questionnaires for qualitative and quantitative feedback on factors which affect completion of study activities, including participant acceptability of study activities
Time frame: from Day 1 to Day 42
Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA)
Number of samples completed in accordance to study protocol, time to complete testing, number of samples tested with stability window
Time frame: from Day 1 to Day 42
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Research Site
St Louis, Missouri, United States
Research Site
Charleston, South Carolina, United States
Research Site
Charlottesville, Virginia, United States