Observational Study of C. Diff in Post-Transplant Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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An International Prospective Observational Study to Assess the Characteristics and Outcomes of Post-transplant Patients Treatment for C. Difficile Infections

Conditions
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Clostridium Difficile

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CDI patients<br>Adults with a first episode of CDI within 2 years after solid-organ or stem-cell transplant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe patients who are successfully treatment for CDI | 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. | 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 | 
| Assay differences across sites | Describe assays used to detect C. difficile organisms and toxin in stool by site at which participants are enrolled. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant