C.Difficile Observational Study

NCT06277999 | Completed

• 1 other identifier: D8820C00001
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 7

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

Conditions

Clostridium Infections

Keywords

Clostridiodes difficile infection, C difficile

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

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

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.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

≥ 18 Years of Age (Adult, Older Adult )

You may qualify if:

• Male or female participants ≥ 18 years of age at the time of signing the informed consent
• 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.
• 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
• Able to complete the Follow-up period through Day 42 based on the assessment of the PI.
• 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.
• Signed and dated written information consent prior to collection and testing of stool samples for participants in the Discard Stool cohort

You may not qualify if:

• 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.
• Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily
• Absence of suitable venous access for serum sampling

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Sacramento, California, 95817, United States

Location

Research Site

Hamden, Connecticut, 06518, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

Charleston, South Carolina, 29425, United States

Location

Research Site

Charlottesville, Virginia, 22903, United States

Location

Related Links

• Redacted CSR Synopsis

Biospecimen

Retention: SAMPLES WITH DNA

stool, serum samples

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: April 22, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (7)