Observational Study of C. Diff in Post-Transplant Patients
CDIFF
An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections
1 other identifier
observational
132
5 countries
9
Brief Summary
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedStudy Start
First participant enrolled
August 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedNovember 1, 2019
October 1, 2019
2.2 years
April 12, 2016
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Response to antibiotic treatment for CDI: clinical cure
The planned first course of CDI treatment was completed with resolution of symptoms or less than 3 loose stools per day for at least two consecutive days maintained until end of treatment and two days after treatment course ended.
90 days
Response to antibiotic treatment for CDI: sustained clinical cure
Clinical cure achieved and maintained for 40 days post treatment initiation without recurrences, complications, ICU with CDI, or death as defined below
90 days
Response to antibiotic treatment for CDI: global cure
Clinical cure achieved and maintained for 90 days post treatment initiation without recurrences, complications, including ICU with CDI, or death as defined below.
90 days
Response to antibiotic treatment for CDI: relapse
A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.
90 days
Response to antibiotic treatment for CDI: reinfection
A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation
90 days
Response to antibiotic treatment for CDI: complications
The study will collect the incidence of specific complications as assessed by the site investigator: perforation of the colon; development of toxic megacolon; need for abdominal surgery related to CDI; transfer to the ICU with CDI; death from CDI-related cause.
90 days
Secondary Outcomes (6)
Describe patients who are successfully treatment for CDI
90 days
Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)
90 days
All-cause mortality
90 days
Response to treatment for CDI (as defined above) by treatment regimen
90 days
Response to treatment for CDI (as defined above) by type of transplant (solid organ vs. hematopoietic/stem cell)
90 days
- +1 more secondary outcomes
Study Arms (1)
CDI patients
Adults with a first episode of CDI within 2 years after solid-organ or stem-cell transplant.
Eligibility Criteria
Adults with a first episode of CDI within 2 years post solid-organ or stem-cell transplant.
You may qualify if:
- 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 (1) presence of diarrhea (at least 3 loose stools within a 24-hour period), AND (2) detection of C. difficile cytotoxin in stools by cytotoxin assay, or toxigenic culture, or polymerase chain reaction (PCR) testing for toxin, or enzyme immunoassay, or endoscopic presence of pseudomembranes with the detection of C. difficile in tissue biopsies
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)collaborator
- Merck Sharp & Dohme LLCcollaborator
- Astellas Pharma Inccollaborator
- Copenhagen HIV Programmecollaborator
- Medical Research Councilcollaborator
- Washington D.C. Veterans Affairs Medical Centercollaborator
Study Sites (9)
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
CHIP, Department of Infectious Diseases, Section 2100
Copenhagen, 2100, Denmark
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
Cologne, Germany
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Doce de Octubre
Madrid, Spain
Related Links
Biospecimen
serum, stool
Study Officials
- STUDY CHAIR
Jean-Michel Molina, MD
Hôpital Saint-Louis, Service de Maladies Infectieuses
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 21, 2016
Study Start
August 22, 2016
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
November 1, 2019
Record last verified: 2019-10