Clostridium InfectionsNCT06277999
C.Difficile Observational Study
An observational study of Clostridium Infections, run by AstraZeneca at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Clostridium Infections
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Apr 2024to 17 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ≥ 18 Years of Age (Adult, Older Adult )
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Charleston, South Carolina, 29425
Research Site
Charlottesville, Virginia, 22903
Research Site
Hamden, Connecticut, 06518
Research Site
Sacramento, California, 95817
Research Site
St Louis, Missouri, 63110
About this 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
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
Read the 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 .
- Conditions
- Clostridium Infections
- Keywords
- Clostridiodes difficile infection, C difficile
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from Day 1 to Day 42
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: from Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start22 Apr 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium InfectionsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277999
- Sponsor's protocol ID
- D8820C00001
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06277999
- Acronym / sponsor ID
- D8820C00001
- Conditions
- Clostridium Infections
- Keywords
- Clostridiodes difficile infection, C difficile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ≥ 18 Years of Age (Adult, Older Adult )
Key inclusion criteria (12 listed)
- 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:
- 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.
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants that completed key study activities according to protocol
Time frame: from Day 1 to Day 42
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.
3 secondary outcomes
Time intervals across stool sample collection logistics
Time frame: from Day 1 to Day 42
Participant Experience and site staff evaluation questionnaires
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)
Time frame: from Day 1 to Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Infections, run by AstraZeneca at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that completed key study activities according to protocol (time frame: from Day 1 to Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.