C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBactolife A/S
About this trial
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:
* What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI? * Does toxin levels of Toxin A and/or B from C. Diff. at baseline predict CDI recurrence risk?
Participants will:
* Undergo standard of care Antibiotic treatment for first recurrence of CDI * Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote/via phone call.)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide signed and dated informed consent
Males and females from the age of 18 and above
Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis/testing algorithms, and antibiotic taper regimes acceptable.
Documented history of, minimum one previous CDI episode occurring within the last 12 months.
Disqualifiers
Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)
Pregnant or lactating women or women who intend/wish to become pregnant in the time period in between screening and visit 4
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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 interventionParticipants that are undergoing standard of care antibiotic treatment for their second C. Diff infection will be followed for 8 weeks after completing antibiotic treatment.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Within the 8 week time period between baseline and end of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov