Clinical trial NCT06277999: C.Difficile Observational Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Infections
Keywords: Clostridiodes difficile infection, C difficile
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ≥ 18 Years of Age (Adult, Older Adult )

Brief 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 ≥ 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

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

1. Male or female participants ≥ 18 years of age at the time of signing the informed consent
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:

1. 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.
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

Primary outcomes:
measure: Number of participants that completed key study activities according to protocol
timeFrame: from Day 1 to Day 42
Secondary outcomes:
measure: Time intervals across stool sample collection logistics
timeFrame: from Day 1 to Day 42
measure: Participant Experience and site staff evaluation questionnaires
timeFrame: from Day 1 to Day 42
measure: Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA)
timeFrame: from Day 1 to Day 42
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Research Site
state: California
city: Hamden
country: United States
facility: Research Site
state: Connecticut
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
Study officials:
References: