Observational Study of C. Diff in Post-Transplant Patients

Completed

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.

Detailed Description: 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. This includes treatment success, recurrence, and complications in a prospectively followed cohort of solid organ and hematopoietic stem cell transplant patients. Patients who develop CDI within 2 years after transplantation will be enrolled and followed prospectively for 90 days after enrollment. Specimens of stool and serum collected within 48 hours of initiation of treatment will be stored locally for future epidemiologic studies to examine the immunologic and microbiologic risk factors for relapse and treatment failure, as well as complications of CDI in the transplant population. Response rates will be classified by organ type, hematopoietic stem cell transplant typ, treatment regimen, and immunosuppressive regimen.

Recruitment & Eligibility

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 (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

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

Primary Outcome Measures

Name	Time	Method
Response to antibiotic treatment for CDI: complications	90 days	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.
Response to antibiotic treatment for CDI: reinfection	90 days	A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation
Response to antibiotic treatment for CDI: clinical cure	90 days	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.
Response to antibiotic treatment for CDI: sustained clinical cure	90 days	Clinical cure achieved and maintained for 40 days post treatment initiation without recurrences, complications, ICU with CDI, or death as defined below
Response to antibiotic treatment for CDI: global cure	90 days	Clinical cure achieved and maintained for 90 days post treatment initiation without recurrences, complications, including ICU with CDI, or death as defined below.
Response to antibiotic treatment for CDI: relapse	90 days	A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.

Secondary Outcome Measures

Name	Time	Method
Describe patients who are successfully treatment for CDI	90 days	Patients will be described by demographics (age, race, sex), type of transplant received, specific treatment for CDI, and the strain of C. difficile with which they were infected.
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
Assay differences across sites	90 days	Describe assays used to detect C. difficile organisms and toxin in stool by site at which participants are enrolled.
Describe differences in antibiotic regimens and other CDI treatments across geographic regions (US, Europe, South America)	90 days

Locations (9): Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV
🇩🇪
Cologne, Germany
University of Minnesota Medical Center
🇺🇸
Minneapolis, Minnesota, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Hospital Universitario Doce de Octubre
🇪🇸
Madrid, Spain
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Hospital Clinic de Barcelona
🇪🇸
Barcelona, Spain
CHIP, Department of Infectious Diseases, Section 2100
🇩🇰
Copenhagen, Denmark