Observational Study of C. Diff in Post-Transplant Patients

University of Minnesota132 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

132

Conditions

Clostridium Difficile

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 90 days

Response to antibiotic treatment for CDI: relapse

A new episode of CDI after clinical cure and within 4 weeks after treatment initiation.

Time frame: 90 days

Response to antibiotic treatment for CDI: reinfection

A new episode of CDI after clinical cure and beyond 4 weeks after treatment initiation

Time frame: 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.

Time frame: 90 days

Secondary Outcomes

Data from ClinicalTrials.gov

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