Observational Study of C. Diff in Post-Transplant Patients

Completed

Conditions studied: Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT02747017

Run by

University of Minnesota

People needed

132

Starts

2016-08-22

Expected to finish

2018-10-30

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• CHIP, Department of Infectious Diseases, Section 2100 — Copenhagen, 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

Full record on ClinicalTrials.gov

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