Observational Study of C. Diff in Post-Transplant Patients (CDIFF)

University of Minnesota (UMN)

Status: Completed

Conditions: Clostridium Difficile

Study type: Observational

Funder types: Other; NETWORK; Industry; Other U.S. Federal agency

Identifiers

NCT02747017

1605M87565

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

132 participants in 1 patient group

CDI patients

Description:

Adults with a first episode of CDI within 2 years after solid-organ or stem-cell transplant.