A Study of the Characteristics and Outcomes of Treatment for C. Diff in Post-Transplant Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-003156
NCT ID: NCT02747017
Sponsor Protocol Number: INSIGHT 007
About this study
The purpose of this study is to estimate the success, recurrence, and complications over the 90 day follow up period for the treatment of C. difficile infection in adult solid organ or stem cell transplant patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years
- Signed informed consent
- Transplant recipient (solid organ, stem cells, or bone marrow) within past 2 years
- Currently diagnosed with first CDI after transplant, defined by
- Presence of diarrhea (at least 3 loose stools within a 24-hour period)
- Detection of C. difficile cytotoxin in stools by
- Cytotoxin assay
- Toxigenic culture
- Polymerase chain reaction (PCR) testing
- Enzyme immunoassay
- Endoscopic presence of pseudomembranes with the detection of C. difficile in tissue biopsies
Exclusion Criteria
- Previous episode of CDI anytime after transplant
- Current treatment for another infectious cause of diarrhea (bacterial, viral, or parasitic) at the time of the current CDI diagnosis
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Zelalem Temesgen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available