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Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations".
The goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection.
The main questions it aims to answer are:
Participants will:
Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under "Contacts and Locations".
This prospective observational study will enrol 60 otherwise healthy adults with a documented history of first recurrent Clostridioides difficile infection (rCDI). Eligible participants must have had a confirmed positive toxin B test for C. difficile, with the initial infection occurring within the past 12 months. At the time of enrolment (Day 0), participants must have completed a standard-of-care oral antibiotic therapy for their first rCDI no more than five days prior and be asymptomatic for CDI. Potential participants will sign an informed consent form at their initial visit to their doctor (visit 1) and provide a stool sample for c diff testing. Participants will only be considered 'enrolled' if their stool sample is positive for toxin B and they meet all other criteria at visit 2 (week 0).
The primary objective of the study is to measure the rate of CDI recurrence within an 8-week follow-up period. The secondary objective is to assess stool levels of Toxin A and B at baseline, week 2, and week 8. The second objective will enable exploration of the reliability of using high-sensitivity assays for toxin detection in stool. Further, potential correlations between post-treatment stool toxin levels and rCDI development will be explored.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment. | Other | Participants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects experiencing CDI recurrence in the time period between baseline and end of study follow-up. | CDI recurrence will be defined as the development of a new episode of diarrhoea (3 or more loose stools in 24 or fewer hours) associated with a positive stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. | Within the 8 week time period between baseline and end of follow-up |
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Participants will be included in the study if they meet all of the following criteria
At the time of screening:
At the Time of Baseline Visit:
- Have completed the antibiotic treatment regime for the current CDI, a maximum of 5 days prior to the baseline visit
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria:
At the time of screening:
At the time of baseline visit:
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This prospective observational study will enrol 60 otherwise healthy adults with a documented history of first recurrent Clostridioides difficile infection (rCDI). Eligible participants must have had a confirmed positive toxin B test for C. difficile, with the initial infection occurring within the past 12 months. At the time of enrolment (Day 0), participants must have completed a standard-of-care oral antibiotic therapy for their first rCDI no more than five days prior and be asymptomatic for CDI. Potential participants will sign an informed consent form at their initial visit to their doctor (visit 1) and provide a stool sample for c diff testing. Participants will only be considered 'enrolled' if their stool sample is positive for toxin B and they meet all criteria at visit 2.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin O' Regan Senior Operations Manager, Atlantia Clinical Trials | Contact | +1 312 818 8905 | koregan@atlantiatrials.com |
| Name | Affiliation | Role |
|---|---|---|
| Brynjulf Mortensen, pHD | Bactolife A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
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Stool samples. DNA sequencing plenned, but only to look at bacterial DNA, not human DNA.
| Corewell Health William Beaumont University Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
|
| Mayo Clinic, Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53705-2281 | United States |
|
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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