C.Difficile Observational Study

Clostridium Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277999
• Other study ID #: D8820C00001
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: October 11, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 Day -5 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 11, 2024
• Est. primary completion date: October 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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:

• 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 no more than 7 days before entry to the study or evidence of pseudomembranes demonstrated by endoscopy or histopathology.

• Receiving SOC therapy (including but not limited to metronidazole, vancomycin, fidaxomicin) for the treatment of CDI, initiated in the prior 5 days, 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

Related Conditions & MeSH terms

• Clostridium Infections
• Infections

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charleston	South Carolina
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	from Day 1 to Day 42
Secondary	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	from Day 1 to Day 42
Secondary	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	from Day 1 to Day 42